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Job DescriptionWhy Joint Academy (Remote Role) Joint Academy is redefining how musculoskeletal (MSK) care is delivered. Our AI-powered platform combines Remote Therapeutic Monitoring (RTM) with a Home Exercise Program, helping PT, orthopedic, and pain-management clinics generate new reimbursable revenue streams while improving patient outcomes. We have a first-mover advantage in a brand-new category and are winning multiple deals as we speak. The opportunity is massive were positioned to become the category leader in a market that will shape the future of MSK and physical therapy. To date, we've treated 200,000+ patients, published 40 peer-reviewed clinical studies, and onboarded thousands of clinicians across many of the worlds largest health systems. Backed by $50 million from leading global investors, were scaling fast and looking for a Customer Success leader to help our partners achieve outstanding results. Why Join Our Customer Success Team * You'll own strategic relationships with innovative Physical Therapy, orthopedic, and MSK clinics adopting digital care. * Massive market tailwind: <1% of 40,000 PT clinics in the U.S. currently monetize RTM correctly. * You'll play a key role in helping clinics grow usage, improve outcomes, and generate new revenue through digital MSK care. * Collaborative, high-performance team in a fast-growing, mission-driven company. The Role You'll act as both a strategic advisor and project manager, ensuring smooth onboarding, adoption, and measurable success across our partner clinics. You'll guide each implementation from kickoff to success, running established project templates and driving execution forward. Responsibilities * Lead onboarding and implementation projects for new clinics, ensuring rapid time-to-value (<30 days to first RTM payment). * Act as a project manager, running through structured implementation templates and ensuring milestones are met. * Build strong relationships with clinic owners, managers, and clinicians to maximize adoption and satisfaction. * Educate physical therapists on how to use our software effectively and invite patients to drive platform engagement and usage. * Identify growth opportunities and create action plans to increase RTM utilization and outcomes. * Collaborate cross-functionally with Sales, Product, and Clinical teams to align on client goals and feedback. * Work within our Customer Success tools to ensure processes, automations, and workflows run smoothly. * Host training sessions, webinars, and check-ins to reinforce best practices and showcase ROI. * Represent Joint Academy at conferences and client events as a trusted advisor in digital MSK care. Who You Are * 5+ years in Customer Success, Account Management, or Implementation for a B2B SaaS company. * Proven project management experience comfortable running structured rollouts and managing timelines. * Track record of driving customer growth, engagement, and retention. * Self-starter with a roll-up-your-sleeves mindset and strong sense of ownership. * Excellent communicator who builds trust and motivates clients to take action. * Experience in healthcare, digital health, or physical therapy is a plus, not required. * Data-driven and process-oriented, with experience using modern CS and CRM platforms. * Willing to travel 10-20% for conferences and client visits. Compensation & Perks * Base salary $110k - $140k + strong performance-based bonus (OTE >$200k). * Meaningful stock options. * Full medical/dental/vision, 401(k) with match, HSA/FSA. * Unlimited PTO, remote-first culture, home-office stipend. * Optional off-sites + wellness perks (cold plunge & sauna access at HQ). Bottom Line Join the company setting the new standard in digital MSK care. As a Customer Success Manager at Joint Academy, you'll act as a project leader, educator, and growth driver helping clinics unlock new revenue, improve patient outcomes, and fully embrace the future of digital physical therapy.

Job Description Echocardiogram Tech Lead, Non-Invasive Vascular Tech Position Summary: Responsible for coordinating and supervising the overall function of the Echo Department and staff. To Perform Adult Echocardiography Competently. Takes On-Call. Monitors supplies. Maintains equipment. Other duties as assigned. Assists with maintaining Infection Control standards. Transports patients. Risk Management. Maintains Inter and Intra-departmental relations. Promotes Guest Relations. Actively seeks Personal Improvement. Trained in echocardiographic examination of patients with adult cardiac diseases. Position Responsibilities: • Serves as a mentor and teacher for new staff and students., • Handles individual problems regarding staff, morale, procedures, salary adjustments, safety, and discipline under the guidance of the Director., • Manages departmental in-service program and keeps track of attendance and topics covered., • Conducts regular staff meetings (huddles)., • Handles the interviewing and hiring process for all supervised employees under the guidance of the Director., • Prepares and reviews employee performance assessments with guidance of the Director., • Attends Hospital Committee meetings as needed., • Creates and organizes work schedules and assigns personnel accordingly., • Ensures adequate staffing to cover absences, time off (vacation, sick, holiday), and Leave of Absence (LOA)., • Handles administrative tasks of the department, including preparation and development of budgets, reports, documents, payroll records, and statistical surveys, and submits them on time to Administration or other agencies., • Manages inventory of technical supplies and coordinates purchasing and inventory control with materials management., • Stays updated on new procedures, equipment, and methods, and participates in their evaluation and use in departmental operations., • Applies age-related knowledge of growth and development as appropriate for the patient population., • Good oral and written communication skills in the English language., • Visual and hearing senses must be adequate to detect changes in human physiological condition., • Able to function calmly in a fast paced, stressful environment., • Experience in echocardiographic examination of patients in any setting including acute care setting., • Performs duties and conducts interpersonal relationships in a manner designed to project a positive image of the department and the hospital., • Works with supervisor/manager and other members of section or department to promote a harmonious work environment., • Ensures that all contacts with patients, the public, physicians, and other hospital personnel are carried out in a friendly, courteous, helpful, and considerate manner., • Answers telephones in a prompt and courteous manner., • Displays concern and aids or explains procedures as appropriate to callers or in face-to-face situations., • Dedicated to meeting the expectations and requirements of internal and external customers., • Holds current BLS card. ACLS card preferred., • Registry in Cardiac Sonography preferred., • Ability to effectively communicate (verbally and in writing) in English., • Ability to write legibly (Clinical Areas)., • Additional languages desirable. Must clear background and drug test required.

Job Description Echocardiogram Tech Lead, Non-Invasive Vascular Tech Position Summary: Responsible for coordinating and supervising the overall function of the Echo Department and staff. To Perform Adult Echocardiography Competently. Takes On-Call. Monitors supplies. Maintains equipment. Other duties as assigned. Assists with maintaining Infection Control standards. Transports patients. Risk Management. Maintains Inter and Intra-departmental relations. Promotes Guest Relations. Actively seeks Personal Improvement. Trained in echocardiographic examination of patients with adult cardiac diseases. Position Responsibilities: • Serves as a mentor and teacher for new staff and students., • Handles individual problems regarding staff, morale, procedures, salary adjustments, safety, and discipline under the guidance of the Director., • Manages departmental in-service program and keeps track of attendance and topics covered., • Conducts regular staff meetings (huddles)., • Handles the interviewing and hiring process for all supervised employees under the guidance of the Director., • Prepares and reviews employee performance assessments with guidance of the Director., • Attends Hospital Committee meetings as needed., • Creates and organizes work schedules and assigns personnel accordingly., • Ensures adequate staffing to cover absences, time off (vacation, sick, holiday), and Leave of Absence (LOA)., • Handles administrative tasks of the department, including preparation and development of budgets, reports, documents, payroll records, and statistical surveys, and submits them on time to Administration or other agencies., • Manages inventory of technical supplies and coordinates purchasing and inventory control with materials management., • Stays updated on new procedures, equipment, and methods, and participates in their evaluation and use in departmental operations., • Applies age-related knowledge of growth and development as appropriate for the patient population., • Good oral and written communication skills in the English language., • Visual and hearing senses must be adequate to detect changes in human physiological condition., • Able to function calmly in a fast paced, stressful environment., • Experience in echocardiographic examination of patients in any setting including acute care setting., • Performs duties and conducts interpersonal relationships in a manner designed to project a positive image of the department and the hospital., • Works with supervisor/manager and other members of section or department to promote a harmonious work environment., • Ensures that all contacts with patients, the public, physicians, and other hospital personnel are carried out in a friendly, courteous, helpful, and considerate manner., • Answers telephones in a prompt and courteous manner., • Displays concern and aids or explains procedures as appropriate to callers or in face-to-face situations., • Dedicated to meeting the expectations and requirements of internal and external customers., • Holds current BLS card. ACLS card preferred., • Registry in Cardiac Sonography preferred., • Ability to effectively communicate (verbally and in writing) in English., • Ability to write legibly (Clinical Areas)., • Additional languages desirable. Must clear background and drug test required.

Job Description WE ARE HEALTHCARE SYSTEMS OF AMERICA. Our mission is to elevate healthcare standards, improve patient outcomes, and create value for communities across the United States. Healthcare Systems of America (HSA) is more than a healthcare provider-we're a community built on excellence, innovation, and compassion. If you're looking for a career that makes a difference, empowers you to grow, and gives you the opportunity to impact lives, HSA is where you belong. Healthcare Systems of America operates 8 community hospitals across 3 states. We service a multitude of patients and their families across our vast network, while remaining committed to the professional development of our staff, the functional improvement of our patients, and the cultivation of strong partnerships within our communities. WHAT WE OFFER • Career Growth & Development - We are an essential, stable and growing company with many opportunities for training and advancement within the medical field that all employees and team members can benefit from., • Supportive & Inclusive Culture - We foster an environment where every team member is valued, heard, and empowered to succeed. This IT Project Manager, Clinical applications plays a pivotal role in ensuring the seamless integration of newly acquired healthcare facilities into the HSA Corporate health system's technology infrastructure. This individual oversees end-to-end IT project execution related to M&A activities, including due diligence, systems assessment, infrastructure alignment, and EMR/EHR onboarding. Working closely with leadership from IT, Clinical operations, compliance, and vendor partners, the Project Manager ensures timely, secure, and cost-effective technology transitions that align with organizational goals and regulatory requirements. The successful candidate will collaborate closely with the Clinical and Ancillary IT Applications teams to support system implementation initiatives across key operational workflows. Focus areas will include, but are not limited to: • Nursing, • Surgical Services and Anesthesia, • Lab/Blood Bank/Pathology, • Pharmacy and Pyxis, • Emergency Department, • Order Entry, • Physician Documentation PRIMARY RESPONSIBILITIES • Lead and manage the full lifecycle of Clinical-related projects, including new system implementations, upgrades, migrations, and optimization efforts., • Collaborate with stakeholders to define project scope, objectives, timelines, and deliverables that support clinical workflow and business needs., • Drive integration efforts between MEDITECH applications and third party systems and modalities, ensuring interoperability, data accuracy, and efficient user workflows., • Coordinate with clinical and ancillary departments, vendors, and IT teams to ensure alignment of system capabilities with end-user requirements., • Develop and maintain detailed project plans, including schedules, milestones, resource allocation, risks, and mitigation strategies., • Track project performance, identify variances, and implement corrective actions as needed to ensure timely and on-budget delivery., • Manage change control, testing coordination, go-live planning, and post-implementation support activities., • Serve as a liaison between clinical leadership, technical teams, and executive sponsors, facilitating clear communication and issue resolution., • Document project status, technical configurations, workflow impacts, and system enhancements., • Support end-user training and knowledge transfer activities to promote system adoption and operational readiness., • Provide project management support for additional IT or clinical projects as needed, based on organizational priorities and PMO resource planning., • Work within a matrixed environment and large-scale implementation Program structure to iteratively deliver projects to meet the overarching goals of the organization and Corporate IT department. EXPERIENCE/EDUCATION REQUIREMENTS • Bachelor's degree in Healthcare Administration, Information Systems, or related field (Master-s degree preferred)., • Minimum of 5 year of project management experience in a healthcare setting with a focus on clinical and/or ancillary systems., • Hands-on experience with MEDITECH EHR is required, particularly in integration or optimization roles., • Previous experience managing large-scale, cross-functional projects in clinical or ancillary environments. SKILLS/REQUIREMENTS • Proficient in healthcare IT standards including HL7, HIPAA, and security/privacy requirements., • Excellent project planning, coordination, and risk management skills., • Strong communication and stakeholder engagement abilities. Capable of working with Executives, IT staff, and vendors., • Ability to balance multiple priorities, navigate complex healthcare environments, and lead cross-functional teams., • Experience using project management tools (e.g. Microsoft Project, Smartsheet, Jira)., • PMP or similar project management certification preferred., • Ability to work independently, proactively resolve issues, and drive initiatives to completion.

Job Description Location: On-Site 4 days per week at our Menlo Park, CA, Princeton, NJ or Miami FL locations About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC) * HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. * HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. * HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. Colorectal Cancer (CRC) * HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview of Role: The Manager, Clinical QA will collaborate closely with Regulatory Affairs, QA, R&D and other cross functional teams within the Company to provide GCP/GLP/GPV and compliance-related advice to internal clinical study teams. This will be accomplished through ensuring tactical support is provided to assignments and wherever necessary, taking the lead in ensuring project related procedural documents, comply to relevant GxP’s and regulatory requirements and guidelines. Role and Responsibilities: * Partnering and collaborating with key stakeholders (R&D teams) to ensure that appropriate Quality support is provided to Summit Clinical and pre-clinical programs * Ensuring end-to-end quality management through proactive compliance based on Clinical Development Plan (CDP) * Liaising with the Global Audits and Compliance function to provide lessons learned from audits and inspections to program teams and support implementation of corrective actions * Supporting CRO-relevant meetings, when necessary, to provide quality overview/ training to relevant stakeholders * Providing support during the development and execution of Corrective and Preventive Actions (CAPAs). Coordinating and reviewing CAPAs to ensure adequate CAPAs are defined, implemented, and closed. * Support formal investigations of issues as they arise, ensuring timely escalation to line management if critical incidents are not resolved in due course * Identifying areas of continuous process improvement and engaging QA and key stakeholders as necessary * QA support in interactions with internal and external contacts and Health Authorities (HA), as appropriate. In collaboration with the Global QA team, ensure inspection management by assisting in preparing program teams for FDA, EU, and key HA pre-approval and sponsor-monitor inspections; provide inspection management support and follow-up post inspections. * Support in providing interpretation of regulations and company process standards, guidelines, policies, and procedures to personnel for assigned programs or for continuous improvement projects * Supporting or leading development and driving the implementation of study/program-specific quality plans to ensure proactive management of quality * Supporting rectifying any necessary vendor-relevant issues identified for the assigned program * Ensuring that protocols for assigned programs can be operationalized and address potential risks with key stakeholders * Perform internal audits as applicable * All other duties as assigned Experience, Education and Specialized Knowledge and Skills: * Bachelor's Degree in Life Sciences, Pharmacy, or Nursing required * Master's Degree or other advanced degree preferred * Minimum of 5+ or more years Quality Assurance experience and or Clinical Operations involvement in regulated activities or equivalent experience required * Broad understanding of global expectations of Health Authorities in the management of clinical trials preferred * Thorough understanding of international GCP/GLP regulations including FDA/EU GCP, ICH, pharmacovigilance, new drug regulations, other key HA guidance’s, and current industry practice preferred • Ability to travel up to 20% Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable * Strong computer and database skills * Attention to detail, accuracy and confidentiality * Clear and concise oral and written communication skills * Excellent organizational skills * Critical thinking, problem solving, ability to work independently * Must be able to effectively multi-task and manage time-sensitive and highly confidential documents * Communicate effectively and articulate complex ideas in an easily understandable way * Prioritize conflicting demands * Work in a fast-paced, demanding and collaborative environment The pay range for this role is $139,000-$163,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.

Job DescriptionWho We Are Galatea Bio is an innovative, venture backed biotechnology company with a mission to advance precision health for all. Founded by pioneers in the human genetics and bioinformatics industry, we identified a major gap in the way underrepresented communities are included in and derive benefit from advances in precision health, such as the development of new tests and cures. The last 20 years have seen an explosion of genetic information and data. New technological advances have made it faster and less expensive to understand the human genomes but most of those resources have focused on northern European communities. The mission of Galatea Bio is to channel the diversity of the world into advancing genomic medicine for the benefit of all. Leveraging clinical-grade biobanking, research and clinical genomics, and best-in-class ancestry and genome annotation algorithms, we will better understand the genetic architecture of underserved populations and power the next generation of precision medicine studies while maintaining an uncompromising commitment to ethical research. Read more at . About this opportunity As our Project Manager you will lead the launch of a new research project, from scratch, ensuring the achievement of milestones and deliverables in a timely manner. Parallel to launch you will also develop our internal knowledge base and establish the infrastructure for future research projects at Galatea Bio; from IRB approvals, to tooling, to documentation and tracking. You will be the liaison between study participants, research staff, and all stakeholders involved with ensuring a successful study. In this role you will report to the VP of Clinical Testing & Quality Control. Responsibilities • Competitive Salary* Eligibility for annual bonus * Stock Options* Health benefits, including dental and vision plans* 401k plan with company match* Flexible PTO* Diverse, inspiring, and highly academic colleagues We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Job Description Location: On-Site 4 days per week at our Menlo Park, CA or Princeton, NJ office. About Summit: Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials: • HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced, or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib)., • HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. Overview of Role: Summit is seeking an experienced, detail-oriented Manager of Clinical Data Management with a strong background in oncology clinical trials. This role will lead and oversee clinical data management activities, ensuring the integrity, quality, and timeliness of clinical data across multiple oncology studies. Role and Responsibilities: • Lead and manage clinical data management activities for oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards., • Provide strategic oversight and direction to CRO clinical data management teams for assigned studies., • Develop and implement data management plans, case report forms (CRFs), edit checks, and data validation plans in alignment with study protocols and regulatory requirements., • Oversee the design, build, and validation of clinical databases using Medidata Rave EDC, ensuring optimal configuration and functionality., • Conduct thorough reviews of clinical data, identifying trends, inconsistencies, and potential issues that may impact data quality or study outcomes., • Collaborate with cross-functional teams including Biostatistics, Clinical Operations, Safety, and Regulatory to ensure alignment of data management strategies with overall clinical development goals., • Provide oversight, and performance management of external data management vendors., • Maintain SOPs, guidelines, and best practices for clinical data management processes., • Represent the Clinical Data Management function in internal and external meetings, providing expert guidance on data-related matters., • Stay current with industry trends, regulatory requirements, and technological advancements in clinical data management, particularly in the oncology field., • Bachelor's degree in Life Sciences, Computer Science, or a related field; advanced degree preferred., • A minimum of 5+ years of clinical data management experience in the biotechnology or pharmaceutical industry., • Experience managing oncology clinical trials data, including a deep understanding of oncology-specific data requirements and challenges., • Expert-level proficiency with Medidata Rave EDC, including system configuration, form design, and edit check programming., • Strong knowledge of clinical research processes, FDA & ICH guidelines, GCP, GCDMP, and CDISC standards., • Demonstrated experience in CRO and vendor oversight., • Excellent project management skills with the ability to manage multiple studies simultaneously., • Strong analytical and problem-solving skills with meticulous attention to detail., • Outstanding communication and interpersonal skills, with the ability to effectively collaborate with diverse stakeholders., • Proficiency in Microsoft Office Suite and familiarity with statistical software (e.g., SAS, R) is a plus., • Preferred Qualifications:, • CCDM® (Certified Clinical Data Manager) certification, • Experience with risk-based monitoring in oncology studies Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.

Job Description Location: Menlo Park, CA, Princeton NJ or Miami FL. onsite 4 days per week About Summit: Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials: • HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced, or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib)., • HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. Overview of Role: The Clinical Trial Manager is a highly autonomous and experienced clinical operations professional responsible for all aspects of Clinical Trial Management for global studies. Responsible for study start up and maintenance through study close out. Coordinates, leads and drives leads Summit cross functional team members, CROs and vendors to successfully deliver clinical studies. Responsible for all performance metrics and quality of deliverables in the clinical trial. Role and Responsibilities: • Oversees study scope, quality, timelines, and budget with the internal Summit functional leads, CRO and vendors to ensure that overall project objectives are met, • Initiates and builds solid professional relationships with key opinion leaders and clinical site staff, • Partners with the CRO to ensure robust patient enrollment strategies are developed and carried out effectively to ensure patient enrollment is completed on time, • Partners with the CRO to ensure robust ongoing data monitoring strategies are developed and carried out effectively to ensure delivery of high-quality data, • Proactive identification and management of study related risks, • Responsible for the development and management of clinical trial documents including (but not limited to) protocols, Case Report Forms (CRFs), consent documents, confidentiality agreements, • Responsible for reviewing and managing study related plans, processes including, • Investigator agreements (CTA), CRFs, CRF guidelines, statistical / pharmacokinetic analysis plans, monitoring plan, data management, safety monitoring, • Responsible for reviewing CRO and vendor contracts/work orders and specifications to enable study objectives to be met, • Reviews and approves essential document packages to enable timely site activations, • Reviews pre-study, study initiation, interim monitoring visit and at study closeout visit report, • Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates, • Directs investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary, • Responsible for oversight on the maintenance of the TMF and completeness at the end of the study, • Perform periodic QC of the TMF, • Oversee the creation and execution of clinical trial activities in accordance with Good Clinical Practices. Ensure compliance of clinical trials with national and international regulatory requirements and co-monitoring the assigned clinical trial following company SOPs, • Ensures the study is “inspection ready” always, • Responsible for oversight and coaching of the functional activities of Clinical Trial Associates allocated to the project, • Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred, • Minimum of 5+ years of clinical project management experience in conducting international clinical trials in sponsor Pharma/Biotech organization, • Prior phase II and III experience required, • A solid understanding of the drug development process, ICH guidelines/GCP and specifically, each step within the clinical trial process, • Experience with budget forecasting and management, • Experience with clinical studies in oncology, • Ability to travel internationally to visit clinical sites and for study meetings. Amount will vary upon project needs (up to 20%), • Proven proficiency in overseeing large complex studies being managed in house and by a CRO, • Demonstrated ability to lead teams and work in a fast-paced team environment, • Experienced and enjoys building relationships with KOLs and site personnel, • Ability to successfully engage and work collaboratively with overseas clinical operations team members/colleagues, • Demonstrated ability to build and deliver on patient enrollment strategies, • Excellent interpersonal and decision-making skills. Demonstrates innovation, possesses drive, energy, and enthusiasm to deliver the program objectives, • Demonstrated ability to comprehend complex scientific concepts and data, • Proficient in reviewing and assessing clinical data, • Possesses excellent planning, time management & coordination skills, • Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs, • Experience in working in a small organization Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.

Job Description Location: Menlo Park, CA; Miami, FL; Princeton, NJ onsite or REMOTE About Summit: Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials: * HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib). * HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. * HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression. Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting. Overview of Role: The Clinical Contracts Manager is responsible for the drafting, negotiation, and execution of company contracts across multiple departments. This position is within the Legal Department and partners with clinical operations, medical affairs, finance, research & development, IT, human resources, facilities, and other internal clients from other departments to draft and negotiate contracts that protect the company from risk, support company business objectives, and ensure compliance with company guidelines. Role and Responsibilities: • Draft, review, analyze and negotiate a wide range of contracts, with an emphasis on clinical trial agreements and ISTs. In addition to clinical trial agreements and ISTs, draft, review, and negotiate agreements with contract research organizations (CROs), sponsored research agreements, advisory board agreements, collaboration agreements, licensing agreements, consulting and contractor agreements, master services agreements and related statements of work, promotional speaker bureau agreements, vendor and service contracts and related work orders, IT/software agreements, facilities and lease agreements, human resource/employee benefit agreements, and confidentiality or non-disclosure agreements., • Acts as the primary contact between the internal business units and external parties, ensuring that all contractual matters are addressed efficiently and promptly; escalate matters, as necessary, to reduce company risk and help ensure company business objectives are met., • Develop strong working relationships with functional groups and project teams., • Promptly respond to complex inquiries regarding contract obligations and revisions., • Prepares and timely disseminates information regarding contract status, compliance, modifications, etc., • Reviews, analyzes and tracks in-process and on-going agreements., • Reports the status of contracts to internal clients using established processes and updated processes as necessary., • Escalate legal issues to the Sr. Corporate Counsel, as needed, • Effectively interact with Intellectual Property Counsel and Compliance to ensure appropriate handling of intellectual property and compliance issues in contract matters., • Effectively interacts with Quality Assurance to ensure appropriate handling of quality matters., • Ensure clear and prompt communication with company employees, and outside parties regarding status of, or issues in, contracts., • Handle miscellaneous tasks or special assignments on an as-needed basis., • Bachelor’s degree in relevant legal or business field, • Minimum of 5+ years of experience with contracting and negotiation, • Extensive clinical trial agreement negotiation and drafting experience (U.S. and ex-U.S.) with a pharmaceutical company, • Precise drafting and negotiation skills, and knowledge of the regulations and statutes and industry guidelines impacting pharmaceutical research, development and commercial contracts, including GDPR and other data privacy laws., • Experience with contract lifecycle management (CLM) systems, • Proficient with Word and have a working knowledge of Excel., • Excellent written and oral communication skills; ability to work effectively and efficiently with all levels of management and personnel., • Able to handle multiple projects in a timely manner, • Strong interpersonal skills including a strong sense of being a team player, • Works well under pressure to meet specific deadlines Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.

Job Description About Company: Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I–IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally. Why join us? We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge. Job Description: The Lab Assistant will perform basic and complex clinical and pharmacokinetic specimen collection and processing (upon assignment) for Phase 1 clinical trials, primarily healthy paid volunteers. Duties will primarily focus on assisting the Lab Manager in processing laboratory samples but will also include clerical and data entry duties. Hours are project dependent and sometimes require weekends and/or very early or late hours. Responsibilities: • Monitor urine collection temperatures, as assigned., • Monitor 24-hour specimen collections (i.e., urine, feces), as assigned., • Maintain sample collection area clean and stocked with all necessary supplies., • Notify appropriate staff of abnormal results while collecting specimens, adverse events, or unusual incidents., • Act as courier to Pharmacokinetic laboratory for collected specimens., • Assure minimal discomfort for study participants while performing all duties., • Maintain safety and well-being of study participants during assigned shift., • Safety lab requisition creation and sample send out to the local labs., • Labeling of PK/PD collection tubes, • Certification as a Phlebotomy Technician and/or a minimum of six months experience working as a phlebotomist at a medical facility., • Clinical Research experience preferred but not required., • BLS and/or ACLS certification preferred but not required., • Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines., • Knowledgeable in medical terminology, • Excellent communication skills (interpersonal, written, verbal), • Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)

Job Description Position Summary: To Perform Adult Echocardiography Competently. Takes On-Call. Monitors supplies. Maintains equipment. Other duties as assigned. Assists with maintaining Infection Control standards. Transports patients. Risk Management. Maintains Inter and Intradepartmental relations. Promotes Guest Relations. Actively seeks Personal Improvement. Trained in echocardiographic examination of patients with adult cardiac diseases. Position Qualification: • Good oral and written communication skills in the English language., • Visual and hearing senses must be adequate to detect changes in human physiological condition., • Able to function calmly in a fast paced, stressful environment., • Experience in echocardiographic examination of patients in any setting including acute care setting., • Performs duties and conducts interpersonal relationships in a manner designed to project a positive image of the department and the hospital., • Works with supervisor/manager and other members of section or department to promote a harmonious work environment., • Ensures that all contacts with patients, the public, physicians and other hospital personnel are carried out in a friendly, courteous, helpful and considerate manner. Answers telephones in a prompt and courteous manner., • Displays concern and provides assistance or explains procedures as appropriate to callers or in face-to-face situations., • Dedicated to meeting the expectations and requirements of internal and external patients, the public, physicians and other hospital personnel., • Holds current BLS card. ACLS card preferred., • Registry in Cardiac Sonography preferred., • Ability to effectively communicate (verbally and in writing) in English., • Ability to write legibly (Clinical Areas)., • Additional languages desirable. Must clear background and drug test required.

Job Description Position Summary: To Perform Adult Echocardiography Competently. Takes On-Call. Monitors supplies. Maintains equipment. Other duties as assigned. Assists with maintaining Infection Control standards. Transports patients. Risk Management. Maintains Inter and Intradepartmental relations. Promotes Guest Relations. Actively seeks Personal Improvement. Trained in echocardiographic examination of patients with adult cardiac diseases. Position Qualification: • Good oral and written communication skills in the English language., • Visual and hearing senses must be adequate to detect changes in human physiological condition., • Able to function calmly in a fast paced, stressful environment., • Experience in echocardiographic examination of patients in any setting including acute care setting., • Performs duties and conducts interpersonal relationships in a manner designed to project a positive image of the department and the hospital., • Works with supervisor/manager and other members of section or department to promote a harmonious work environment., • Ensures that all contacts with patients, the public, physicians and other hospital personnel are carried out in a friendly, courteous, helpful and considerate manner. Answers telephones in a prompt and courteous manner., • Displays concern and provides assistance or explains procedures as appropriate to callers or in face-to-face situations., • Dedicated to meeting the expectations and requirements of internal and external patients, the public, physicians and other hospital personnel., • Holds current BLS card. ACLS card preferred., • Registry in Cardiac Sonography preferred., • Ability to effectively communicate (verbally and in writing) in English., • Ability to write legibly (Clinical Areas)., • Additional languages desirable. Must clear background and drug test required.

Job Description Position Summary: To Perform Adult Echocardiography Competently. Takes On-Call. Monitors supplies. Maintains equipment. Other duties as assigned. Assists with maintaining Infection Control standards. Transports patients. Risk Management. Maintains Inter and Intradepartmental relations. Promotes Guest Relations. Actively seeks Personal Improvement. Trained in echocardiographic examination of patients with adult cardiac diseases. Position Qualification: • Good oral and written communication skills in the English language., • Visual and hearing senses must be adequate to detect changes in human physiological condition., • Able to function calmly in a fast paced, stressful environment., • Experience in echocardiographic examination of patients in any setting including acute care setting., • Performs duties and conducts interpersonal relationships in a manner designed to project a positive image of the department and the hospital., • Works with supervisor/manager and other members of section or department to promote a harmonious work environment., • Ensures that all contacts with patients, the public, physicians and other hospital personnel are carried out in a friendly, courteous, helpful and considerate manner. Answers telephones in a prompt and courteous manner., • Displays concern and provides assistance or explains procedures as appropriate to callers or in face-to-face situations., • Dedicated to meeting the expectations and requirements of internal and external patients, the public, physicians and other hospital personnel., • Holds current BLS card. ACLS card preferred., • Registry in Cardiac Sonography preferred., • Ability to effectively communicate (verbally and in writing) in English., • Ability to write legibly (Clinical Areas)., • Additional languages desirable. Must clear background and drug test required.

Job Description Occupational Therapist (In Patient- Full Time) Location: Miami, FL Schedule: M-F, 8a-5p Pay: $34.51 - $51.77 Position Responsibilities: • Initiates and/or completes patient assessment, following time frames established in departmental guidelines, to determine treatment required and completes documentation as observed by supervisor or during chart review., • Performs thorough assessment of patient’s functional conditions to set plan of treatment with appropriate short and long-term goals., • Updates patient’s progress and goals, as evidenced by appropriate documentation., • Documents charges with each initial evaluation and daily treatment as appropriate and as observed by supervisor and other department personnel., • Completes Outcome Measure scores for admission, goal setting and discharge within departmental policies and procedures in a timely manner., • Modifies treatment approach based on patient’s reaction to it and reassesses outcome as observed by supervisor., • Fits, trains and educates patients in use of assistive devices, DME/adaptive equipment and ensures that all equipment is ordered, received and measured to fit each patient as observed by supervisor and as documented in the chart., • Provides written instructions, training and education as needed to all patients/family member/caretakers, in a timely manner, as evidenced by documentation of such in the patient’s chart., • Performs training in functional activities (negotiation of architectural barriers, transfers, job task requirements, etc.) ADL’s/IADL’s to have patient reach highest level of independence., • Gives at least one in-service annually to staff., • Voluntarily assist other therapists/assistants in completing their work and serves as a clinical expert for less experienced staff, as observed by supervisor and staff., • Participates in the clinical education program (student program) as reported by the coordinator for clinical education., • Takes initiative in developing or assisting supervisor on new programs including Performance Improvement and cost containment issues as observed by supervisor/manager., • Current Florida State OT License. CPR Certification, • Graduate of an accredited Occupational Therapy Program in accordance with state licensing requirements. Taken or is willing to take postgraduate education, • 12 months of clinical work experience; working towards approved project or at least 12 CEHs per year in specialty area (Neuro, Cardiac, Ortho).

Job Description Physical Therapist Location: Miami Beach, Florida Pay Range: $34.51 - $51.77 Schedule: M-F Full Time Position Responsibilities: • Initiates and/or completes patient assessment, following time frames established in departmental guidelines, to determine treatment required and completes documentation as observed by supervisor or during chart review., • Performs thorough assessment of patient’s functional conditions to set plan of treatment with appropriate short and long-term goals., • Updates patient’s progress and goals, as evidenced by appropriate documentation., • Documents charges with each initial evaluation and daily treatment as appropriate and as observed by supervisor and other department personnel., • Completes Outcome Measure scores for admission, goal setting and discharge within departmental policies and procedures in a timely manner., • Modifies treatment approach based on patient’s reaction to it and reassesses outcome as observed by supervisor., • Fits, trains and educates patients in use of assistive devices, DME/adaptive equipment and ensures that all equipment is ordered, received and measured to fit each patient as observed by supervisor and as documented in the chart., • Provides written instructions, training and education as needed to all patients/family member/caretakers, in a timely manner, as evidenced by documentation of such in the patient’s chart., • Performs training in functional activities (negotiation of architectural barriers, transfers, job task requirements, etc.) ADL’s/IADL’s to have patient reach highest level of independence., • Gives at least one in-service annually to staff., • Voluntarily assist other therapists/assistants in completing their work and serves as a clinical expert for less experienced staff, as observed by supervisor and staff., • Participates in the clinical education program (student program) as reported by the coordinator for clinical education., • Takes initiative in developing or assisting supervisor on new programs including Performance Improvement and cost containment issues as observed by supervisor/manager., • Current Florida State PT License. CPR Certification., • Graduate of an accredited Physical Therapy Program in accordance with state licensing requirements. Taken or is willing to take postgraduate education., • 12 months of clinical work experience or graduate of a doctorate degree program; working towards approved project or at least 12 CEHs per year in specialty area (Neuro, Cardiac, Ortho).

Job DescriptionCompany Description KIPP Miami is part of the KIPP (Knowledge is Power Program) national nonprofit network of college-preparatory, public charter schools educating elementary, middle and high school students. KIPP has a 25-year track record of preparing students for success in college and life. Founded in 2018, KIPP Miami operates two nonprofit charter schools in Greater Miami’s Urban Core community. Currently, KIPP Miami educates students in grades K-4 at KIPP Royalty Academy and 5-8 students at KIPP Courage Academy. To learn more, visit or visit us on instagram Opening with an inaugural ninth-grade class in school year 2026-2027 and growing to serve grades 9–12, KIPP Miami Tech will provide students with the academic foundation, professional skills, and real-world experiences necessary to excel in college or career pathways. KIPP Miami Tech will offer three specialized career academies: Business, Commercial & Digital Arts, and Technology. Students will be able to graduate not only with a high school diploma, but also with college credits, industry-recognized credentials, and hands-on experience that provide a head start on their futures. Applicants, please note that this role has a projected start date in July 2026 Job Description KIPP Miami seeks an experienced High School Academy Teacher to play a key role in the build‑out of KIPP Miami Technical High School’s academies in Business, Commercial & Digital Arts, and Technology. The ideal candidate has a proven record teaching high school and will design innovative, career‑aligned courses that prepare students for postsecondary pathways and industry certifications. The teacher will integrate career and technical education (CTE) strands and deliver rigorous, college‑preparatory instruction with real‑world application, modeled after the standards of high‑performing programs in the South Florida community and nationally. What We’re Looking For • Innovative Instructor: You deliver engaging, culturally responsive instruction that bridges classroom learning with real‑world applications in Business, Commercial & Digital Arts, and Technology., • Academy Builder: You support the launch and expansion of KIPP Miami Technical High School’s academies while aligning courses to AP, AICE, IB, and Dual Enrollment pathways., • CTE Integrator: You ensure students earn meaningful certifications and exposure to industry standards across Business, Technology, and Health Sciences., • Data‑Driven & Reflective: You use evidence to refine instruction and accelerate student growth. Instruction & Curriculum • Design and implement rigorous academy/magnet curriculum in Business, Commercial & Digital Arts, and Technology that aligns with Florida B.E.S.T. Standards, Miami‑Dade advanced program expectations, and CTE frameworks., • Lead engaging, project‑based learning that integrates industry‑specific knowledge and interdisciplinary themes (e.g., entrepreneurship, digital design, health sciences, IT systems, finance, biotechnology)., • Provide students with authentic experiences such as simulations, case studies, clinical labs, coding projects, and business plan development., • Create common assessments, capstone projects, and industry‑specific performance tasks; analyze student performance data to refine instruction., • Collaborate with school leaders to support the design, launch, and growth of academies in Business, Commercial & Digital Arts, and Technology, • Embed CTE competencies and prepare students for industry certifications relevant to their academy pathway (e.g., QuickBooks/Entrepreneurship for Business; CompTIA IT Fundamentals, Coding Certifications for Technology;), • Model and uphold KIPP Miami’s Heartbeat Principles in all interactions; build an inclusive, aspirational classroom culture that fosters belonging and joy., • Serve as a program ambassador; build strong community and industry partnerships that enhance the Business, Commercial & Digital Arts, and Technology academies., • Provide oversight of tier 1 tech support, • Coordinate student and staff device deployment, • Check-in with regional tech manager regularly on state of technology at schoolQualifications Required Education & Experience • Bachelor's degree is required, • A degree in Business, Commercial & Digital Arts, and Technology or a related field is preferred., • At least two (2) years of full‑time high school teaching experience. (required)., • Demonstrated ability to deliver rigorous instruction, integrate project‑based learning, and maintain strong student outcomes., • Valid Florida Educator Certificate (or eligibility) in a 6-12 subject area and/or aligned to the magnet/academy theme. (Candidates pursuing reciprocity or temporary certification must be eligible under Florida statutes.), • Prior success teaching in academy/magnet programs or advanced academic settings., • Experience integrating CTE content and preparing students for industry certifications in Business, Commercial & Digital Arts, and Technology., • Demonstrated ability to partner with external organizations for student internships, mentorships, and authentic learning opportunities., • Commitment to complete required CTE coursework and pass state CTE examinations relevant to assigned pathways within the first 24 months of employment (tuition/fees may be eligible for reimbursement per KIPP Miami policy)., • Strong proficiency with instructional technology and data‑driven decision‑making. The usual and customary methods of performing the job’s functions require the following physical demands: • Prolonged periods of sitting at computer or working at desk and significant fine finger dexterity., • Often required to stand and sit. Skills and Abilities • Commitment to KIPP Miami’s mission, vision and goals, • Passion for working with children and school personnel, • Prior success teaching in academy/magnet programs or advanced academic settings., • Experience integrating CTE content and preparing students for industry certifications in Business, Commercial & Digital Arts, and Technology., • ESOL endorsement or willingness to obtain within required timelines; additional endorsements (e.g., Gifted, Reading) a plus., • Demonstrated ability to partner with external organizations for student internships, mentorships, and authentic learning opportunities., • Excellent communication and interpersonal skills, with ability to engage and work closely with a wide range of staff members and external partners, • Strong organization skills and meticulous attention to detail, • Flexibility and willingness to learn, • Growth Mindset, • Commitment to do whatever it takes to ensure our students have what they need to be successful, • Proficient in Microsoft Office, specifically Excel, • Data base management and reporting, • Strong written and oral communication skills, • Strong interpersonal skills, • Demonstrated ability to work with a team on collaborative projects, • Ability to use the computer to input student data., • Ability to effectively plan, organize and implement curricula and activities., • Ability to make decisions on behalf of children and protect their well-being., • Must be able to manage confidential information., • Ability to maintain professionalism and emotional constancy., • Ability to work flexible hours., • Ability to work with a team on collaborative projects, • Ability to proactively problem solve; anticipate challenges before they occur, • Ability to identify inefficiencies and generate creative solutions, • Ability to manage multiple projects simultaneously and comfortably with ambiguity, • Degree and/or substantive career experience in Business, Technology, or Health Sciences., • Proficiency in Spanish and/or Creole, preferred, • Experience in high‑performing school environments with a record of student growth and equitable outcomes. Additional Information Compensation & Benefits The salary range for this role is $55,550-$62,250, commensurate with experience. KIPP Miami offers a full comprehensive benefits plan, including health care, competitive 403(B) plan, and a school laptop. Our organization is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, gender, age, religion, national origin, citizen status, marital status, physical or mental disability, military or veteran status, sexual orientation, gender identity, or any other characteristic protected by applicable law. Our organization will make a reasonable accommodation to known physical or mental limitations of a qualified applicant or employee with a disability unless the accommodation would impose an undue hardship on the operation of the organization. No questions on this application are asked for any unlawful purpose. #LI-MIA

Job Description Position Summary: To Perform Adult Echocardiography Competently. Takes On-Call. Monitors supplies. Maintains equipment. Other duties as assigned. Assists with maintaining Infection Control standards. Transports patients. Risk Management. Maintains Inter and Intradepartmental relations. Promotes Guest Relations. Actively seeks Personal Improvement. Trained in echocardiographic examination of patients with adult cardiac diseases. Position Qualification: • Good oral and written communication skills in the English language., • Visual and hearing senses must be adequate to detect changes in human physiological condition., • Able to function calmly in a fast paced, stressful environment., • Experience in echocardiographic examination of patients in any setting including acute care setting., • Performs duties and conducts interpersonal relationships in a manner designed to project a positive image of the department and the hospital., • Works with supervisor/manager and other members of section or department to promote a harmonious work environment., • Ensures that all contacts with patients, the public, physicians and other hospital personnel are carried out in a friendly, courteous, helpful and considerate manner. Answers telephones in a prompt and courteous manner., • Displays concern and provides assistance or explains procedures as appropriate to callers or in face-to-face situations., • Dedicated to meeting the expectations and requirements of internal and external patients, the public, physicians and other hospital personnel., • Holds current BLS card. ACLS card preferred., • Registry in Cardiac Sonography preferred., • Ability to effectively communicate (verbally and in writing) in English., • Ability to write legibly (Clinical Areas)., • Additional languages desirable. Must clear background and drug test required.

Job Description Position Summary: To Perform Adult Echocardiography Competently. Takes On-Call. Monitors supplies. Maintains equipment. Other duties as assigned. Assists with maintaining Infection Control standards. Transports patients. Risk Management. Maintains Inter and Intradepartmental relations. Promotes Guest Relations. Actively seeks Personal Improvement. Trained in echocardiographic examination of patients with adult cardiac diseases. Position Qualification: • Good oral and written communication skills in the English language., • Visual and hearing senses must be adequate to detect changes in human physiological condition., • Able to function calmly in a fast paced, stressful environment., • Experience in echocardiographic examination of patients in any setting including acute care setting., • Performs duties and conducts interpersonal relationships in a manner designed to project a positive image of the department and the hospital., • Works with supervisor/manager and other members of section or department to promote a harmonious work environment., • Ensures that all contacts with patients, the public, physicians and other hospital personnel are carried out in a friendly, courteous, helpful and considerate manner. Answers telephones in a prompt and courteous manner., • Displays concern and provides assistance or explains procedures as appropriate to callers or in face-to-face situations., • Dedicated to meeting the expectations and requirements of internal and external patients, the public, physicians and other hospital personnel., • Holds current BLS card. ACLS card preferred., • Registry in Cardiac Sonography preferred., • Ability to effectively communicate (verbally and in writing) in English., • Ability to write legibly (Clinical Areas)., • Additional languages desirable. Must clear background and drug test required.

Job Description Job Summary The Lead Contract Services Manager (LCSM) is responsible for overseeing, directing, and supervising Contract Services Managers (CSMs) located at various IHSC field sites. This position is designed to provide flexibility, as it is remote with required travel. The LCSM plays a crucial role in ensuring the efficient management of contract services, maintaining compliance with IHSC policies, and ensuring that contract staff are properly trained and supported. Key responsibilities include providing training and orientation to new CSMs, developing and implementing backup plans for each site to ensure CSM coverage, and overseeing contractor productivity and policy compliance. The LCSM also works closely with Government Technical Monitors (GTMs), Contracting Officers (COs), and other leadership to ensure coordination and effective management of staffing and resources. This role requires a proactive approach to problem-solving, quality improvement, and ensuring high standards of care and service across all locations. Classification Full-Time, Exempt Job Duties Staff Supervision and Management: • Oversee, direct, and supervise Contract Services Managers (CSMs) at various IHSC field sites., • Serve as Key Personnel, providing broad front-line supervision and management to all contract staff within assigned regions., • Plan, schedule, assign, and direct contract staff to ensure coverage and continuity of care across all sites., • Coordinate and conduct site visits for staff candidates, ensuring proper selection and onboarding., • Perform personnel and human resource functions, including conducting staff evaluations at 90 days post-hire and annually thereafter., • Establish and maintain a strong and positive working relationship with on-site Government Technical Monitors (GTMs), Contracting Officers (CO), and Contracting Officer Representatives (COR)., • Meet regularly with GTMs to ensure coordination and collaboration of staffing., • Provide training and orientation to new and existing CSMs, ensuring they are well-versed in protocols, requirements, and the specifics of the patient population., • Lead or delegate discipline-specific clinical and administrative in-services for contract staff in accordance with agency policies and accreditation standards., • Ensure that all new contract personnel are trained in accordance with licensing scope and agency policies., • Participate in analyzing established protocol practices, identifying areas for improvement, and developing corrective action plans., • Assist with program/project design, strategy development, problem resolution, and implementation., • Assist in developing recommendations for improved efficiency in patient care and service delivery., • Participate in safety, infection control, quality improvement, and patient education initiatives., • Produce reports on contractor productivity and monitor compliance with IHSC policies, procedures, and accreditation standards., • Review patient records to assess the adequacy of record-keeping, implementation of clinical guidelines, and policy compliance., • Monitor contractor performance and compliance with 23 key performance indicators (KPIs), including staffing fill rates, backfill rates, and meeting training and orientation requirements., • Draft weekly status updates summarizing compliance with KPIs and contractor performance., • Coordinate with the CO, COR, Program Management Team, and other InGenesis leadership to ensure smooth operations and address any concerns., • Perform other duties assigned, including attending and participating in general, quality assurance, medical, and clinical staff meetings., • Support and promote the organization's commitment to success in all staffing and operational decisions., • Assist in troubleshooting and resolving issues related to staffing, contracts, or operations., • Bachelor’s degree from an accredited university recognized by the Department of Education (DOE) in business, healthcare, or related field., • Minimum five years of administrative healthcare management experience with demonstrated success managing remote staff and multiple locations., • Proven ability to provide supervision, training, and orientation to diverse teams across dispersed locations., • Excellent organizational skills, capable of managing multiple concurrent tasks effectively., • Strong interpersonal and communication skills, adept at interacting with individuals from diverse backgrounds and building collaborative relationships., • Demonstrated ability to develop and maintain effective working relationships with government stakeholders (e.g., GTM, CO, COR)., • Experience in monitoring compliance with policies, evaluating staff performance, and implementing corrective actions., • Ability and willingness to travel 30% to 40% as required., • Knowledge of effective supervision and staff administration: Demonstrated ability to lead a multidisciplinary workforce, manage remote teams, and provide clear direction and support., • Staff Development: Knowledge of adult learning principles and ability to train and develop staff effectively, ensuring they meet operational and performance standards., • Licensing & Certification Requirements: Understanding the licensing and certification requirements for professional disciplines operating in clinical settings., • Adaptability and Flexibility: Ability to adapt quickly to changes in schedules, priorities, and operational demands., • Multicultural Competence: Ability to work effectively in a multi-cultural and multi-lingual environment, fostering inclusivity and respect., • Effective Communication: Strong verbal and written communication skills to develop positive rapport with staff, government stakeholders, and other partners., • Electronic Systems Proficiency: Ability to navigate electronic systems, including Electronic Health Records (EHR), web-based training tools, and communications platforms., • Microsoft Office Skills: Proficiency in Microsoft Office Suite (Word, Excel, Outlook, SharePoint) for creating reports, analyzing data, and communicating effectively., • HIPAA Compliance: In-depth knowledge of privacy regulations (HIPAA) regarding the confidentiality of patient records and Personally Identifiable Information (PII). Duty Hours/On-Call Requirements • Facilities operate 24/7/365; this position is required to respond during an emergency activation., • This full-time position, or designee vendor equivalent, is required to be available telephonically to respond to the local GTM during non-duty hours., • The work requires some physical exertion, such as long periods of standing, walking, and/or jogging unaided over rough, uneven, or rocky surfaces; recurring bending, crouching, stooping, stretching, reaching, or similar activities; or recurring lifting of moderately heavy patients or equipment., • The work may require specific, but common, physical characteristics and abilities, such as agility and dexterity, visual, and hearing capabilities., • Must be able to respond to any medical emergency in the facility, via foot, within four minutes and perform CPR/emergency care standing or kneeling., • Must have the ability to assist sick, injured, or aging detainees or staff exiting the building during an emergency. Requires Access to Sensitive Information: Yes/No ·

Job Description Location: On-Site 4 days per week at our Menlo Park, CA, Princeton, NJ or Miami FL locations About Summit: Ivonescimab, known as SMT112, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), with three active Phase III trials: • HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced, or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib)., • HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. Overview of Role: We are seeking an experienced and highly motivated Manager to join our team. This role is crucial in managing site agreements to support our programs. The ideal candidate will have extensive experience in site contract and budget negotiation, as well as managing relationships with clinical research sites. You will support clinical benchmarking and site budget development, escalation, and payment activities for the Clinical Operations department. You will partner with functional leads of departments to establish strategic approaches to fair market value negotiations and enable site activations. Role and Responsibilities: • Under minimal guidance, develop pricing strategies for site budgets to enable contract execution and site activation, • Collaborate with legal, finance, CRO and clinical teams to ensure site agreements comply with regulatory and company standards, • Negotiate and finalize site agreements, including budgets, contracts, and other necessary documentation. Knowledge of CTA legal risks and possible fallback language required, • Rigorous analysis of budgets with the goal of securing the best price, • Confidently present the budget to the Chief Accounting Officer for approval, ensuring full knowledge of all details, • Partner with Clinical Finance team to provide study-wide site payment estimates and forecasts, • Work with legal counsel to ensure appropriate indemnification, liability, and confidentiality provisions are included in contracts, • Provide regular updates to study management on progress and key performance indicators related to trial agreements, • Work with Finance and Clinical Leadership as needed to address budget, invoice, payment, and PO concerns, • Collaborate with external functional service providers (FSP) on site budget templates, study-level work orders and POs, and site payment processes, • Build and maintain strong relationships with CROs, FSP providers, and clinical sites, • Monitor FSP providers and ensure adherence to project timelines, quality standards, and contractual obligations, • Ensure timely and cost-effective solutions that meet project timelines and budgets, • Address and resolve any issues or disputes related to site agreements, • Collaborate with internal stakeholders, such as Legal, Clinical Operations and Clinical Development, • Develop and implement innovative ideas and solutions to increase the efficiency of the department, • Bachelor’s degree in Life Sciences, Business Administration or related field required, • A minimum of 4+ years’ experience with clinical trial site agreements in biotech or pharmaceutical setting, • Experience in oncology is highly desirable, • Strong global negotiation and contract management skills, • Experience in clinical operations and/or study start up, • Strong financial acumen and ability to understand and create budgets, • Experience working with site budgets on a global scale, and potential internal escalation pathway, • Strong knowledge of using grant plan or similar benchmarking tool, • Expertise in large, multi-site, clinical trials with multiple vendor types is preferred, • Direct negotiating with sites and vendors is a must, • Good understanding of the clinical process is important, • Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable, • Strong computer and database skills, • Attention to detail, accuracy, and confidentiality, • Clear and concise oral and written communication skills, • Excellent communication, interpersonal and organizational skills, • Critical thinking, problem solving, ability to work independently, • Must be able to effectively multi-task and manage time-sensitive and highly confidential documents, • Prioritize conflicting demands, • Work in a fast-paced, demanding, and collaborative environment Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.

Job Description WE ARE HEALTHCARE SYSTEMS OF AMERICA. Our mission is to elevate healthcare standards, improve patient outcomes, and create value for communities across the United States. Healthcare Systems of America (HSA) is more than a healthcare provider-we're a community built on excellence, innovation, and compassion. If you're looking for a career that makes a difference, empowers you to grow, and gives you the opportunity to impact lives, HSA is where you belong. Healthcare Systems of America operates 8 community hospitals across 3 states. We service a multitude of patients and their families across our vast network, while remaining committed to the professional development of our staff, the functional improvement of our patients, and the cultivation of strong partnerships within our communities. WHAT WE OFFER • Career Growth & Development - We are an essential, stable and growing company with many opportunities for training and advancement within the medical field that all employees and team members can benefit from., • Supportive & Inclusive Culture - We foster an environment where every team member is valued, heard, and empowered to succeed., • Meaningful Work - Every day, you'll contribute to patient care, cutting-edge medical solutions, and life-changing treatment and technologies. POSITION SUMMARY We're building a hospital network from the ground up-no legacy systems, no outdated workflows, just a bold vision for scalable, tech-enabled care. As Program Manager for Imaging & Integration, you'll lead two critical workstreams: • Enterprise Imaging Systems (PACS, DICOM workflows, vendor coordination), • Clinical System Interoperability (HL7, FHIR, EMPI, and interface architecture) This is a dual-responsibility role that blends strategic oversight with hands-on delivery. You'll guide the design, development, and deployment of interoperability and imaging infrastructure across a multi-hospital environment-partnering with clinical, technical, and executive stakeholders to make it all happen. PRIMARY RESPONSIBILITIES • Lead full lifecycle delivery of HL7 and FHIR integrations across EHRs, LIS, RIS, PACS, and third-party systems., • Architect and implement workflows for the Enterprise Master Patient Index (EMPI)., • Define integration strategies, data flows, and interface specifications in collaboration with engineering and clinical teams., • Establish governance frameworks for interoperability, message validation, and data mapping., • Oversee PACS-related initiatives including new implementations, upgrades, migrations, and optimization., • Drive integration between PACS and MEDITECH, ensuring seamless workflows and data fidelity., • Develop and manage detailed project plans, milestones, resource allocation, and risk mitigation., • Track performance metrics and implement corrective actions to ensure timely, on-budget delivery., • Coordinate change management, testing, go-live planning, and post-launch support., • Act as liaison between clinical leadership, IT teams, and executive sponsors., • Support training and knowledge transfer to ensure operational readiness., • Operate within a matrixed program structure to deliver iterative value across the organization., • Develop integrated roadmap for Integration, Imaging, and other critical path projects., • Provide PM support for additional IT or clinical initiatives as needed. EXPERIENCE/EDUCATION REQUIREMENTS • Bachelor's degree in Healthcare Administration, Information Systems, or related field (Master's degree preferred)., • 7+ years of healthcare IT program/project management experience., • Proven success in greenfield of M&A environments. SKILLS/REQUIREMENTS • Hands-on experience with PACS platforms (Optum GE, Fuji, Sectra, Philips, etc)., • Strong knowledge of HL7, FHIR, interface engines (Mirth, Rhapsody) and clinical workflows., • Experience with MEDITECH EHR required., • Deep understanding of DICOM, RESTful APIs, and healthcare data exchange standards., • Proficiency in HIPAA, HL7, and security/privacy compliance., • Exceptional planning, coordination, and stakeholder engagement skills., • Capable of managing direct reports and aligning broader teams toward shared goals., • Ability to lead cross-functional teams and manage multiple priorities., • Familiarity with project management tools (e.g. Microsoft Project, ServiceNow SPM Smartsheet, Jira).

Clinical Data Manager, Senior Clinical Data Manager, Principal Data Manager, or Data Management Project Manager. We innovate connections that expedite the development and commercialization of new medical treatments, aiming for improved patient outcomes and enhanced public health worldwide. Step forw

Job Description HEDIS Program Manager About us: Solis Health Plans is a new kind of Medicare Advantage company. We provide solutions that are transparent, connected, and effective for both our members and providers. Solis was created with a desire to offer a more personalized experience throughout every stage of the healthcare journey. Our team consists of experts who take pride in delivering quality service. We foster a culture of collaboration and support, where success is shared, and every employee is valued. To learn more about us, please visit our website at ! **Position is fully onsite Monday-Friday Location: 9250 NW 36th St, Miami, FL 33178. Bilingual in English & Spanish and/or Creole is preferred Full benefits package offered on the first day of the month following the date of hire including: Medical, Dental, Vision, 401K plan with a 100% company match! Our health plan membership has grown exponentially from 2,000 to almost 15,000 members in the last year! Join our winning Solis Team! Position Summary: This position is responsible for overseeing HEDIS and quality measure projects, managing project plans, vendors, and timelines, and collaborating with various internal and external teams to improve HEDIS compliance and audit readiness. Key duties involve leading outreach efforts for members and providers, performing medical record reviews, and analyzing data to identify gaps and drive performance improvement initiatives. Essential Functions and Duties: • Project and program management: Develop and manage project plans, timelines, and deliverables for HEDIS initiatives. This includes ensuring projects adhere to quality standards and managing project budgets., • HEDIS operations and audits: Oversee HEDIS data submission, auditing, and hybrid chart abstraction processes. Act as a subject matter expert during the annual HEDIS audit., • Stakeholder collaboration: Collaborate with internal and external stakeholders, including clinical, operations, and compliance teams, as well as providers and vendors., • Performance improvement: Drive performance improvement by analyzing data, identifying gaps in care, and developing and implementing action plans. This includes developing strategies for member and provider outreach., • Data analysis and reporting: Oversee HEDIS performance data, create and summarize reports for management, and validate dashboards for executive stakeholders., • Communication: Communicate project status, risks, and issues effectively to all stakeholders., • Training and education: Facilitate HEDIS-related training and educational materials for internal staff, providers, and members., • Bachelor’s degree in science or healthcare and/or equivalent relevant experience in the HEDIS project under a managed care organization, • 3+ year of quality management or project management experience is required, • Experience with HEDIS, NCQA (National Committee for Quality Assurance), and CMS Star ratings programs., • Strong project management, organizational, and communication skills., • Excellent analytical and problem-solving skills., • Experience with data analysis and reporting., • Ability to manage multiple complex projects simultaneously., • Familiarity with health plan operations, medical records, and quality metrics., • Strong attention to detail and documentation skills., • Proficiency with Microsoft Office applications., • Proficient with technology and computers, • Self-starter and independent worker, • Managed care experience is preferred, • Year-round record review experience is preferred Required Languages: What sets us apart: Join Solis Health Plans as a HEDIS Program Manager and become a catalyst for positive change in the lives of our members. At Solis, you will be part of a locally rooted organization deeply committed to understanding and serving our communities. If you are eager to embark on a purpose-driven career that promises growth and the chance to make a significant impact, we encourage you to explore the opportunities available at Solis Health Plans. Join us and be the difference.

Job Description Job Title: Recruitment Manager About Company: Who is ERG? ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with an expertise in early and late-stage neuroscience drug development. With 19 wholly owned clinical sites and 5 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 340+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, Acute and Chronic Pain, diabetes and other illnesses as well as normal healthy volunteers who participate in trials for the advancement of medicine. With access to over 32 million patients/subjects and 5000 + completed trials, ERG continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs in the United States and globally. Job Description: The Recruitment Manager assists Centralized Recruitment and manages assigned tasks related to the coordination, planning, and implementation of Patient Recruitment and Retention support operational plans at the Site Level. Communicates with recruitment coordinators to implement and monitor impact of the recruitment/retention plans and create and provide project reporting. Collaborates with internal teams and external providers to coordinate aspects of tactics associated with the recruitment/retention strategy. May assist Centralized Recruitment to represent Site at site/sponsor-facing meetings, train recruitment coordinators and site staff, and conduct recruitment support outreach as required. Responsibilities: Project Management • Assist Site Director and Centralized Recruitment in completion of the scope of work, objectives, quality of deliverables, and other activities of projects as deemed necessary., • Assist in coordination of project activities for team members regarding their project-oriented tasks to ensure that project milestones are met., • Assist in tracking resources to ensure adequate coverage to meet project deliverables and milestones., • Provide technical support as necessary on project specific and interdepartmental training efforts., • Communicate with sites regarding Recruitment and Retention activities, including but not limited to, making follow-up calls regarding patient referrals, tracking logs, receipt of Recruitment and Retention materials, etc., • Become proficient in the functionality of CTMS as it relates to Site’s patient database and gain a full understanding of how new/existing patient information should be captured and updated., • Document and maintain all Company processes for fielding and inputting new patient screenings (phone, web submission, in-person)., • Document and maintain all Company processes for, regularly updating existing patient information in CTMS., • Manage and maintain data tracking entries into designated tracking systems and tools in accordance with project requirements., • Assist and maintain data tracking entries into designated tracking systems and tools in accordance with project requirements., • Assist Centralized Recruitment with periodic report generation and review., • Manage site recruitment team consisting of recruiters and outreach employees., • Ensure recruitment staff are adequately trained and adhere to Standard Operating Procedures and working guidelines while performing duties on assigned studies., • Education and experience, • Bachelor's degree and 5 years of experience in sales, marketing, communications, or outreach activities., • Demonstrate knowledge of the sites clinical research studies as well as the diagnoses and medical terminology that is involved in each study., • Responsible for understanding the protocols and exclusions and a comprehensive understanding of each trial being conducted., • Study, learn, and comply with ERG/Site standard operation procedures, other policies, practices, and regulations where applicable., • Prior experience in clinical research, patient recruitment experience preferred., • Establish clear direction and lays out work in a well-planned and organized manner., • Deal with performance or problem direct reports in a timely manner., • Requirements, • Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines., • Knowledgeable in medical terminology, • Excellent time-management skills, • Excellent communication skills (interpersonal, written, verbal), • Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager), • Scheduled on-call availability of varying degrees based on demands of specific studies, staff availability, and coordination of schedules.

Job Description Location: Princeton, NJ / Miami, FL / Menlo Park, CA / Oxford, UK ONSITE About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC) * HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. * HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. * HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. Colorectal Cancer (CRC) * HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview of Role: We are seeking an experienced clinical supplies professional to join the CMC team and support the supply chain strategy for clinical development. The Clinical Supply Manager will be responsible for planning and execution of operations for their assigned clinical supply projects and to support the ongoing development pipeline as well as optimization of Clinical Supplies department processes. The candidate must have demonstrated effective collaborative skills to work across various phases of clinical development and serve as a key supply chain expert for cross functional teams. Prior experience in a small to mid-sized, fast-paced pharmaceutical environment is preferred. Summit are a global company; overseeing global activities across multiple time zones and as such may require flexibility in working hours at times. Travelling for the role (vendor facility visits, Investigator Meetings, etc) will be required at times and is estimated to be 5-10%. Role and Responsibilities: • Clinical Trial Supply Planning and Forecasting, • Develop and maintain accurate forecasts for clinical trial supplies based on protocol requirements and enrolment projections., • Collaborate with cross-functional teams to ensure alignment of clinical trial supply plans with study timelines and milestones., • Vendor Management, • Oversee relationships with external vendors, including clinical packaging and labelling partners, distribution centres, and courier services., • Monitor vendor performance, adherence to timelines, and quality standards., • Inventory Management, • Implement and maintain robust inventory management systems to track and manage clinical trial supplies throughout the supply chain., • Ensure adequate and timely supply of investigational products to clinical sites., • Oversee the planning, implementation and utilisation of effective clinical systems to support inventory management and distribution (e.g. IxRT)., • Regulatory Compliance, • Stay up to date on relevant regulatory requirements and guidelines related to clinical supply chain management., • Support regulatory strategy by overseeing provision of required documentation for submission and QP certification as required., • Ensure all activities comply with Good Manufacturing Practice (GMP) and other applicable regulations., • Risk Management, • Identify potential risks and challenges in the clinical supply chain and develop mitigation plans., • Proactively address issues that may impact the availability of clinical trial materials., • Communication and Collaboration, • Foster effective communication and collaboration with internal stakeholders, including Clinical Operations, Regulatory Affairs, Quality Assurance, and other relevant departments., • Participate in project team meetings to provide updates on clinical supply chain status and address any issues or concerns., • Contribute to monthly review cycles to ensure cross functional alignment on strategic and tactical topics., • Bachelor's degree in a relevant scientific or business discipline; advanced degree preferred., • Minimum 5 years’ experience in Supplies management at a pharma, biotech or contract development and manufacturing organization (CDMO), • Proficiency in relevant software applications (e.g., Microsoft Office, clinical trial management systems)., • Demonstrated track record of successfully managing complex international clinical studies and supply chains., • Broad understanding of regulatory and GMP requirements for IMP product packaging and supply., • Solid understanding and experience in design specifications and UAT of IXRS applications., • Project management skills, tools, principles, and applications, • Expertise in outsourcing and supplier management, • Proficiency with clinical supply planning and forecasting tools, • Successful candidate will be:, • Comfortable interacting with all levels of the organization, customers, and suppliers, • Able to work with abstract global problems, • Nimble in a highly dynamic and agile organization where changing priorities are the norm, • Intuitive with well-honed interpersonal and communication skills, • Organized and demonstrates effective team leadership, • Effective with global workgroup associates, • A promotor of inclusion and collaboration, • Able to work independently, • Able to handle multiple projects simultaneously while maintaining high-quality results, • Capable of providing and implementing innovative solutions to unique and pressing situations, • Aware and compliant with FDA, EMA, PMDA regulations and requirements for functioning under GMP, GCPs, Annex 13, and EU CT Directive/Regulation, • Able to demonstrate a fundamental knowledge of drug development process, • Technically proficient in industry standard technology and/or available software, processes, and industry trends to streamline and or improve efficiencies, • Knowledgeable of and compliant with SOPs, Change Controls, Deviations, Investigations and CAPAs The pay range for this role is $118,500-$139,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.

Clinical Data Manager, Senior Clinical Data Manager, Lead Data Manager, Principal Data Manager, and/or Data Management Project Manager. IQVIA is seeking experienced Clinical Data Management Leads to oversee end-to-end data management delivery for global clinical trials. Oversee SAE, PK, and external

Responsible for supporting and training end users on clinical systems functionality and workflows, ensuring optimal use of clinical technology to achieve system wide strategic priorities. Utilizes process improvement and change management skills to promote improved quality and process efficiencies t

Job Description Position Summary: We are seeking a highly experienced and motivated Manager, Regulatory Affairs, to join our growing Regulatory Affairs team in Miami. This role is critical to ensuring compliance with US regulatory requirements and supporting the development, approval, and lifecycle management of medical devices. The ideal candidate will possess deep expertise in U.S. FDA regulations, and have a good general understanding of EU MDR, and international standards, and will contribute to strategic regulatory planning and execution. Essential Duties and Responsibilities · Lead regulatory strategy and submissions for Class II and III medical devices in the U.S. · Prepare and manage regulatory submissions including 510(k), PMA Supplements, annual reports. · Serve as the US regulatory lead on cross-functional project teams, ensuring alignment with clinical, quality, and R&D functions. · Interpret and apply regulatory requirements to product development, labeling, and review of advertising and promotional materials. · Monitor changes in regulatory requirements and communicate impact to internal stakeholders. · Support audits and inspections by regulatory authorities. · Lead post-market regulatory assessments and submissions, including periodic reports, vigilance reporting, and regulatory renewals. · Manage complaint handling activities, ensuring timely investigation, documentation, and regulatory reporting in compliance with applicable standards. Qualifications: · Bachelor’s degree in engineering, life sciences, pharmacy, or related field. Advanced degree preferred. · Minimum 10 years of experience in regulatory affairs within the medical device industry. · Proven track record of successful submissions to FDA. · In-depth knowledge of FDA 21 CFR 820, ISO 13485, and other applicable standards. · Strong communication, leadership, and project management skills. · Experience with eQMS systems and electronic document control preferred.