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Job Summary: The Study Lead will oversee the planning, execution, and management of clinical trials from start to finish. This role involves coordinating study activities, ensuring compliance with regulatory requirements, and leading a team of CRAs while collaborating closely with cross-functional teams. The ideal candidate will have a strong background in clinical trial management and a passion for advancing medical research. Key Responsibilities: • Lead the planning, execution, and management of clinical trials in accordance with GCP, regulatory guidelines, and company SOPs., • Develop and manage study protocols, informed consent forms, and other essential study documentation., • Serve as the primary point of contact for all study-related inquiries and issues., • Coordinate with site personnel, vendors, and internal teams to ensure smooth study execution., • Monitor study progress and conduct regular reviews of study data to ensure integrity and compliance., • Provide training and mentorship to CRAs and other study team members., • Assist in the selection and evaluation of clinical sites and vendors., • Prepare and present study updates to senior management and stakeholders., • Participate in regulatory submissions and inspections as needed., • Identify and mitigate study-related risks proactively. Qualifications: • Bachelor’s degree in life sciences or a related field; advanced degree preferred., • Minimum 3 years of experience in clinical trial management or CRA role, preferably in a biotech environment., • Strong understanding of clinical trial regulations and Good Clinical Practice (GCP)., • Excellent organizational and project management skills., • Strong interpersonal and communication skills, with the ability to work collaboratively in a team-oriented environment., • Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems., • Ability to work independently and adapt to changing priorities in a fast-paced environment.

Position Title: Medical Director, Clinical Development TA: women's health, dermatology, or pediatric development Assignment Duration: 6 months Work Location: Remote Work Arrangement: Remote Qualifications: Education / Certificates: MD, DO, or MRCP Experience 4-6 years experience in clinical development in a biotech or pharma setting. Relevant clinical experience in women's health, dermatology, or pediatric development is preferred. Investigators with substantial clinical trial leadership or relevant research experience in an academic setting will also be considered. Skills (professional and/or technical) Strong written and oral communication skills. Fluent in written and spoken English. Travel may be required to support clinical trials or external engagement. Competencies Familiarity with ICH, GCP, clinical trial execution including medical monitoring processes. Stays up to date with and uses relevant regulatory guidances, precedents, scientific literature and therapeutic landscape to anticipate risks and mitigations to clinical trial design and regulatory strategy. Critically analyzes data quality and interpretation. Collaborates with a one team mindset, fosters diverse perspectives, and leads matrixed team through complex decisions. Functions with high level of independence. Able to prioritize and deliver work, and adapt to changing corporate priorities, in a rapidly evolving environment. Possess a high degree of integrity and personal ethics. Responsibilities: Position Overview: The Medical Director role works closely with the Executive Director, Clinical Development, and is responsible for protocol design and scientific oversight of clinical research studies involving new or marketed drugs. S/he will contribute to the clinical development and regulatory strategy for assigned assets, and will also be accountable for the design, execution, oversight, monitoring and report of clinical trials. This position reports into the Executive Director in the Global Clinical Development group within the Clinical Development and Operations organization. Primary Responsibilities Protocol design and study execution: Lead or contribute to the development and updates to the global clinical development plan. Work closely with Operations and vendor to identify and/or vet sites for clinical trial participation Design patient-centered clinical protocols that support strategic objectives, are feasibly conducted, and support efficient recruitment to meet program timelines. Represent clinical development on study teams, collaborating closely with clinical operations and team members in identifying clinical study issues, barriers to execution, and developing sound strategic solutions with partners of the study team to ensure timely resolution. Provide clinical input to clinical study teams for key documents, including informed consent, data review plans, medical monitoring plans, statistical analysis plans, clinical review forms, case report forms, data edit checks Participate in design and conduct of Investigator Meetings for clinical trials Monitor study conduct to ensure efficient recruitment, high quality of data and fidelity to protocol, and to minimize compliance and quality risks to enable a decisive readout. In collaboration with biostats and safety, interpret efficacy and safety data from clinical trials and author CSR. Medical monitoring: Directly monitor and provide oversight to CRO medical monitors, depending on the study execution model, to ensure patient safety and high-quality trial conduct. Monitor study safety and provide input to safety narratives and reports. Regulatory Strategy and Submissions: Collaborate with regulatory affairs on the clinical development and regulatory strategy to result in successful global submissions and approvals, integrating clinical, regulatory, market access and commercial considerations Author and edit regulatory documents, including but not limited to briefing packages, response documents, and submission dossiers. External engagement: Coauthor abstracts and publications and review IIS proposals as requested. Build strong relationships with medical affairs and external thought leaders in supporting clinical development objectives. Plan and execute advisory boards to support clinical development objectives. Build strong relationships with patient advocacy groups to support patient-centered clinical development across all phases of development Collaborate with medical affairs and commercial organization on life cycle management opportunities that generate value for the asset. Participate in due diligence projects as requested to support assessment of external assets

Make your mark for patients We are looking for a Global Quality Auditing Lead REMS / GVP & GCP to join our Global Quality Auditing team based out of Raleigh, NC, Atlanta, GA or Boston, MA About the role The Global Quality Lead for REMS/GVP & GCP programs will co-create and implement the strategy and delivery of a risk based audit program covering the quality and compliance of the UCB REMS (Risk Evaluation & Mitigation Strategies) and Clinical Trials programs. They are responsible for providing input to processes and areas impacted by REMS, Good Pharmacovigilance Practice (GVP) and Good Clinical Practices (GCP) with respect to the requirements of global and local regulations, guidelines and industry best practice. Who you'll work with This individual will work closely with UCB's Global Quality Auditing team and inferface directly with representatives from Regulatory Authorities across the world in association with Inspections of the REMS/Pharmacovigilance System and Clinical Practices. What you'll do Lead and/or participate in the development of the risk based REMS & GCP audit program through evaluation of elements of the UCB quality system and their effect on the overall state of compliance of the system. Plan, conduct, and report on REMS audits of Specialty Pharmacies (SPs), Specialty Distributors (SDs) and program vendors as well as internal system audit to assess compliance with REMS requirements Perform qualification PV audits of potential new vendors/partners/ Specialty Pharmacies (SPs), Specialty Distributors (SDs) and Coordinating Centres (CC). Perform GCP audits of potential new vendors/partners for purposes of qualification prior to contractual relationships. Proactively manage audit findings and CAPAs arising from audits in the Audit Management Tool, using all reasonable efforts to obtain prompt mitigation of deficiencies by responsible functions/persons and escalating concerns as required to senior management. Manage external auditors and/or vendors as required, ensuring that findings from pharmacovigilance audits are distributed, and responses and CAPAs are tracked and followed up as necessary in the Audit Management Tool. Support the preparation, hosting and follow up of Regulatory Authority inspections related to REMS/pharmacovigilance and clinical activities at the site inspected, in collaboration with the R&D Quality Management team. Through active participation to several forums (eg PV Quality Council…) and through direct interaction with colleagues, escalate concerns and provide expert guidance on PV and GCP compliance issues to support the development and implementation of necessary CAPAs and quality improvement measures. Utilize in-depth knowledge and understanding of current business trends, applicable regulations and quality principles, to collaborate effectively and influence approaches to quality, and ensure work products and output are aligned with regulatory guidelines Interested? For this role we're looking for the following education, experience and skills Bachelors Degree required 3+ years auditing experience in the relevant GVP/REMS-GCP area 10+ years in the pharmaceutical environment In-depth knowledge and understanding of REMS/Pharmacovigilance and ICH-GCP, applicable regulations (domestic and international), quality principles, relevant business processes and techniques. Understanding of regulatory requirements for the implementation and maintenance of a REMS compliance program Practical application of US FDA regulatory requirements Fluent in written and spoken English. Additional language skills would be an advantage. Able to travel nationally and internationally as business necessitates, 30% of time on average. Preferred: Masters Degree strongly preferred * Certification (Describe): ISO 9001 lead auditor certification as a nice to have, etc.) Internal applicants should be in their current job for at least 12 months, must meet performance standards and are not on formal corrective/disciplinary process (PIP), warning, final warning, or compliance warning letters within the last 12 months. Please inform your Manager or your Talent Partner before applying to any internal job opportunities. Unless explicitly stated in the description, this role is hybrid with 40% of your time spent in the office, regardless of your current contractual agreement. If your current working arrangements differ, please contact your Talent Partner to discuss before submitting your application. UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable federal, state, or local law. UCB invites you to voluntarily self-identify during the application process. Provision of self-identification information is entirely voluntary and a decision to provide or not provide such information will not have any effect on your application for employment, your employment with UCB, or otherwise subject you to any adverse treatment. Any information you provide will be considered confidential and will be kept separate from your application and/or personnel file and will only be used in accordance with applicable laws, orders, and regulations. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on US-Reasonable_Accommodation@ucb.com for application to US based roles. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel. Requisition ID: 92393 Recruiter: Rachel Kielb Hiring Manager: Bertrand Sailly Talent Partner: Sandrine Eelbo Job Level: MM I Please consult HRAnswers for more information on job levels.

Job Description About Cleerly We're Cleerly – a healthcare company that's revolutionizing how heart disease is diagnosed, treated, and tracked. We were founded in 2017 by one of the world's leading cardiologists and are a growing team of world-class engineering, operations, medical affairs, marketing, and sales leaders. We raised $223M in Series C funding in 2022 which has enabled rapid growth and continued support of our mission. In December 2024 we received an additional $106M in a Series C extension funding. Most of our teams work remotely and have access to our offices in Denver, Colorado, New, York, New York, Dallas, Texas, and Lisbon, Portugal with some roles requiring you to be on-site in a location. Cleerly has created a new standard of care for heart disease through value-based, AI-driven precision diagnostic solutions with the goal of helping prevent heart attacks. Our technology goes beyond traditional measures of heart disease by enabling comprehensive quantification and characterization of atherosclerosis, or plaque buildup, in each of the heart arteries. Cleerly's solutions are supported by more than a decade of performing some of the world's largest clinical trials to identify important findings beyond symptoms that increase a person's risk of heart attacks. At Cleerly, we collaborate digitally and use a wide variety of systems. Our people use Google Workspace (GMail, Drive, Docs, Sheets, Slides), Slack, Confluence/Jira, and Zoom Video, prior experience in these areas is a plus. Role or department specific technology needs may vary and will be listed as requirements in the job description. While we are mostly a remote company, travel is required for some team meetings and cross function projects typically once per month or once per quarter, for some roles like sales or external facing roles travel could be up to 90% of the time.Cleerly is committed to providing safe and effective medical software that meets customer needs and our intended use. The adherence to all applicable regulatory and statutory requirements establishes a clear framework for setting measurable quality objectives. Our commitment to continually improving our products and processes proactively manages risks, ensuring ongoing compliance throughout the entire software lifecycle. Understanding this role's relevance and importance is critical to achieving Cleerly's quality objectives. About the Opportunity Our commercial team is growing and looking for a Clinical Account Manager based in Nashville/Raleigh to help support our growth. You will play a critical role in supporting Cleerly's growth and success of current clients/partners by making sure they understand our product offerings and helping patients get Cleerly scans. Reporting to the Regional Director of Sales, this role will be working with clinical partners to find expansion opportunities as well as to provide ongoing clinical education to grow existing Cleerly accounts. You will be responsible for identifying growth opportunities, maintaining relationships with existing high-value partners, and representing Cleerly as a leader in the industry to positively impact the lives of millions. The ideal candidate is highly motivated, has a clinical background, is client focused, result-oriented, and mission-driven. You will work with clinics to ensure that they are extremely successful with Cleerly's cardiovascular diagnostic technology by proactively supporting, educating, and providing high customer satisfaction. This is a customer- facing role with a primary focus on spending time with customers including Cardiologists. This is a field-based role, but you must be based in or near Nashville/Raleigh, as it will be a key market in your assigned territory. Responsibilities Manage and maintain relationships with clinical partners to make sure they understand Cleerly and how Cleerly helps Providers in their treatment decisions for patients. Account development - Experience building and supporting strong clinical programs is preferred. Clinical / technical proficiency - Quick learner able to grasp new clinical/technical information and then disseminate to customers. Develop relationships with key account stakeholders, to include admin, admin support, key cardiologists, key referring physician practices, and key strategic personnel to drive awareness of Cleerly's offerings and promote adoption. Customer-focused mentality. Drive new product and technology introductions for existing customers. Develop a qualified lead funnel within the existing base. Regular activities consist of formal presentations, peer-to-peer education, new physician training, and driving physician education. Use Salesforce.com to manage administrative tasks. Travel to various provider sites within a territory 50-80% of the time including the following states: NC, TN Requirements • Degree from accredited college/university., • 5+ years of related sales or clinical experience (PA, NP, DNP or RN)., • Prior experience in medical device, cardiology pharmaceuticals, cardiology radio-pharmaceuticals, hospital, or medical software is highly desired. • Highly coachable with the ability to learn and communicate complex programs and value propositions. • Strong interpersonal and relationship-building skills, polished communications, the ability to manage multiple customer and internal company interactions. • Effective project management skills while embracing change and driving solutions in otherwise chaotic environments. • Exceptional written and verbal communication skills., • A hard-worker, self-motivator with can-do approach and bias for action., • Highly responsive with the ability to interpret appropriate next step actions., • Ability to collaborate cross-functionally with both internal and external stakeholders across a vast geographic region. • Experience with introducing new cardiovascular technologies into hospitals is highly desired. • Ability to accurately assess and understand different stakeholders needs/wants. Process cross functional agendas and adjust strategy to achieve desired outcomes. • Grit, high integrity, values-based work ethic. The base salary range for this role is aligned to market benchmarks and determined by experience, skills, and internal equity. This role is eligible for annual On Target Commission, resulting in the following base salary and Total Target Compensation (TTC) ranges: • Base Salary: $130,000 - $140,000, • Commission: $90,000, • TTC: $220,000 - $230,000 *Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.) Additionally, stock options, paid benefits, and employee perks are part of your total rewards. Working at Cleerly takes HEART. Discover our Core Values: • H: Humility- be a servant leader, • E: Excellence- deliver world-changing results, • A: Accountability- do what you say; expect the same from others, • R: Remarkable- inspire & innovate with impact, • T: Teamwork- together we win Don't meet 100 percent of the qualifications? Apply anyway and help us diversify our candidate pool and workforce. We value experience, whether gained formally or informally on the job or through other experiences. Job duties, activities and responsibilities are subject to change by our company. OUR COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER. We do not discriminate on the basis of race, color, national origin, ancestry, citizenship status, protected veteran status, religion, physical or mental disability, marital status, sex, sexual orientation, gender identity or expression, age, or any other basis protected by law, ordinance, or regulation. For more information see our Privacy Policy (https://cleerlyhealth.com/privacy-policy). All official emails will come from @cleerlyhealth.com email accounts. #Cleerly

Job Description RQM+ is The MedTech CRO, accelerating innovation to patient impact. Our tailored solutions deliver regulatory and quality expertise, FDA-recognized laboratory services, clinical trials, and reimbursement strategies across device types and therapeutic areas to bring life-changing technologies to patients — faster, safer, better. We don’t make MedTech. We make MedTech happen. Our experienced teams are cohesive, collaborative, and proactive, constantly seeking to improve and evolve while remaining laser-focused on customer success. RQM+ elevates the MedTech experience through best-in-class service and clear, concise communication. We serve as an extension of our customers establishing and maintaining excellent client and site relationships and providing direct access to our technology platforms for real-time data and study transparency. Job Summary: The Clinical Trial Associate supports the Clinical Trials team(s) in the overall management and administration of trials, including planning, execution, and closeout of one or more clinical trials in a fast-paced environment. The primary responsibility is to independently manage clinical study tasks on behalf of the team in compliance with protocols, SOPs, GCP and applicable regulatory requirements. Primary Responsibilities: • Provides support to the Clinical Project Manager and all Functional Management, including:, • Creating and maintaining internal files for consistent organization of documents, • Scheduling and managing attendance for project (internal and external) and functional team meetings, as requested, • Generating meeting agendas and taking minutes from meetings, • Support for binders, • Support the day-to-day tasks of the Clinical Trial team(s), including monitoring visit preparation, tracking of study document collection by site or by topic, • Assist with study start-up activities, • Maintain audit ready filing in the (electronic) Trial Master File (eTMF), • Complete routine QC checks of eTMF and corrects discrepancies, • Assist with the creation and distribution of Investigator Site Files as needed, • Support CRA with site monitoring visit preparation, • Support IRB submissions and regulatory document collection as needed, • Assist with preparation of reports and/or requests as required, • Maintains activities in the Clinical Trial Management System, • Responsible for tracking and maintaining site status, milestones, and deliverables, • Other duties as assigned, • Support departmental initiatives and process improvements., • Minimal travel required (10% both international and domestic) Education/Work Experience: • B.S/B.A. degree is preferred., • Science/health care related field preferred but not required., • Minimum 1 year of professional experience or equivalent is preferred., • Prior experience in the biotech, pharmaceutical, or medical device industry is preferred. Behaviors: Action-Oriented, Approachability, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Customer Focus, Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning Requirements: • Ability to organize and manage multiple priorities and/or projects, • Ability to manage time, plan, and organize effectively, • Ability to work independently, • Strong written and verbal communication skills, • Attention to detail and thorough follow-up skills, • Participate in coordination of clinical trial related activities, • Demonstrated computer skills (Microsoft Suite), • Maintenance and management of study/program trackers, • Knowledge of ICH/GCP/local regulations, • Effectively and efficiently interact with internal and external personnel Supervisory Responsibilities: This position does not have supervisory responsibilities. Work Environment/Physical Demands: This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers and filing cabinets. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift or move objects up to 10 pounds and occasionally lift or move objects up to 25 pounds. Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today! We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us. Job Opportunity Verification At RQM+, we prioritize the security of our job applicants. To ensure a safe application process: All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careers Every candidate going through the interview process will participate in a voice and/or video interview. Exercise caution with unsolicited job offers or requests for sensitive information.

Job DescriptionCompany Description M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance. Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data. Due to our continued growth, we are hiring for a Site Manager at Wake Research, an M3 company. This position is 100% onsite and located at our Raleigh, NC site. Job Description The Clinical Research Site Manager will work closely with leadership to provide oversight for all clinical trial activities at the site. This role is responsible for ensuring study execution, participant safety, regulatory compliance, data quality, and achievement of site performance goals. The Site Manager works closely with the Principal Investigator (PI), Regional Director, sponsors, CROs, and cross-functional teams to drive operational excellence and successful study outcomes. Essential Duties and Responsibilities Including, but not limited to: • Oversee daily site operations and ensure compliance with study protocols, GCP, ICH guidelines, and company SOPs., • Manage all phases of clinical trial execution, including study start-up, enrollment, conduct, and close-out., • Lead site feasibility assessments and support pre-study qualification visits with sponsors and CROs., • Partner with the Regional Director to manage site financial performance, including budget review, resource allocation, and cost management., • Collaborate with Business Development on new study opportunities, start-up timelines, and enrollment forecasting., • Supervise, mentor, and develop clinical and administrative staff, fostering a collaborative and high-performing team environment., • Oversee participant scheduling, site workflow, and resource utilization to support efficient operations., • Monitor key performance indicators (KPIs) and implement strategies to drive study success and operational excellence., • Review monitoring visit reports and ensure timely implementation of corrective and preventive actions (CAPAs) when required., • Serve as the primary operational contact for sponsors, monitors, CROs, and internal leadership., • Ensure timely and accurate source documentation, EDC data entry, and query resolution., • Support the PI and study team in maintaining participant safety, protocol compliance, and data integrity., • Lead study team meetings, site initiation visits, and cross-functional operational discussions., • Partner with Quality and Compliance teams to prepare for sponsor audits and regulatory inspections., • Identify operational gaps and lead continuous improvement initiatives to enhance site performance., • Mentor and train new investigators on company processes, SOPs, and organizational standards., • Collaborate effectively with multidisciplinary teams across the organization., • Plan and participate in community outreach and recruitment initiatives to increase site visibility and participant enrollment.Qualifications, • Bachelor's degree or equivalent and relevant formal academic experience., • Certified Clinical Research Coordinator (CCRC), Certified Clinical Research Associate (CCRA) or equivalent certification, preferred., • 5+ years of relevant experience as a clinical research associate or clinical research coordinator is required. Must have experience managing trials., • Knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs. Solid teamwork, organizational, interpersonal, attention to detail, and problem-solving skills., • Strong written and verbal communication skills. An ability to consume, absorb, and analyze large amounts of information., • Ability to multi-task, work under time constraints, work independently and cooperatively with interdisciplinary teams., • Strong computer skills in appropriate software and related company clinical systems are required Additional Information About M3: M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we’ve seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems. Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements. Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA. Benefits: A career opportunity with M3 Wake Research offers competitive wages, and benefits such as: • 401(k), 401(k) matching, • Dental insurance, • Disability insurance, • Employee assistance program, • Flexible spending account, • Health insurance, • Life insurance, • Paid time off, • Vision insurance *M3 reserves the right to change this job description to meet the business needs of the organization #LI-Onsite #LI-LB1

Job DescriptionCompany Description M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance. Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data. Due to our continued growth, we are hiring for a Director of Business Development at Wake Research, an M3 company. This is a remote position with up to 25% domestic-travel. Job Description The Director of Business Development leads the growth and management of key strategic partner accounts, expanding relationships across new markets and territories. This role collaborates closely with executive leadership to evaluate prospective partners, assess market trends, and drive overall growth strategy. Operating with a high degree of autonomy, the Director oversees strategic account planning, proposal development, and pipeline management. The role requires strong executive presence and the ability to engage effectively with client leadership to advance strategic partnerships. What You’ll Do: • Achieve annual sales and revenue targets through strategic partnerships within the clinical research and trial services space., • Expand existing sponsor and CRO relationships by identifying new study opportunities, therapeutic areas, and geographic growth markets., • Build and maintain strong client relationships with key decision-makers, including clinical operations and executive leadership., • Develop and execute strategic account plans aligned with client pipeline needs and M3 Wake Research site capabilities., • Lead client presentations and proposals that effectively position multi-site clinical research solutions and differentiated enrollment performance., • Manage business development pipeline, forecasting, and cross-functional coordination to secure new clinical trial placements., • Identify cross-selling opportunities across research services and ensure high client satisfaction, retention, and long-term partnership growth., • Provide regular performance updates and strategic insights to senior leadership., • Support business development activities requiring approximately 25% domestic travel, including conferences and site visits.Qualifications, • Bachelor’s degree in life sciences or business preferred, • Minimum of 5 years of sales experience selling site or CRO services to pharmaceutical and biotech clients, with direct engagement at mid-level and executive decision-maker levels, • Demonstrated strength in consultative selling, communication, and executive-level presentations, with the ability to build and sustain strategic client relationships, • Proven track record of client retention and long-term account growth, • Ability to effectively manage complex client relationships and challenging financial scenarios, • Demonstrated success in acquiring new business and expanding an existing client base Additional Information About M3: M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we’ve seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems. Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements. Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA. Benefits: A career opportunity with M3 Wake Research offers competitive wages, and benefits such as: • 401(k), 401(k) matching, • Dental insurance, • Disability insurance, • Employee assistance program, • Flexible spending account, • Health insurance, • Life insurance, • Paid time off, • Vision insurance *M3 reserves the right to change this job description to meet the business needs of the organization #LI-Remote #LI-LB1

Job DescriptionCompany Description M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance. Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data. Due to our continued growth, we are hiring for a Clinical Research Coordinator at Wake Research, an M3 company. This position is on-site and located in Raleigh, NC. Job Description The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the guidance of the clinical research site management and Principal Investigator (PI). While the PI is primarily responsible for the overall conduct of the clinical trial, the CRC manages, supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. Essential Duties and Responsibilities: • Assisting trial Investigator in screening and review of potential study participants eligibility, • Maintaining case report forms, charts and documentation, • Mentoring, training, and high-level oversight of other clinical research coordinators and research assistants, • Ensuring that all clinical activities are carried out in accordance with established research protocol and standards in compliance with all applicable laws, regulations, policies, and procedural requirements, • Collecting and entering data as necessary, • Assist management with potential new hire selection and shadowing process, • Assist with study start-up, maintenance, and close-out of studies as needed for those on the team, • Ability to be flexible with study assignmentsQualifications, • Clinical Research Coordinator with 1-2 years of experience, • Phlebotomy experience is highly preferred, • Excellent verbal & written communication skills, • Ability to learn quickly, read and understand complex protocols, follow very detailed directions, and multi-tasking, • Must be able to maintain strict confidentiality of patients, employees, and company information at all times and adhere to HIPAA Guidelines, • Extensive clinical trial knowledge through education and/or experience, • Successful completion of GCP Certification and Advanced CRC preferred, • Detail-oriented, • Familiarity with the Code of Federal Regulations as they pertain to human subject protection, • Strong interpersonal skills Additional Information About M3: M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we’ve seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems. Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements. Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA. Benefits: A career opportunity with M3 Wake Research offers competitive wages, and benefits such as: • 401(k), 401(k) matching, • Dental insurance, • Disability insurance, • Employee assistance program, • Flexible spending account, • Health insurance, • Life insurance, • Paid time off, • Vision insurance *M3 reserves the right to change this job description to meet the business needs of the organization #LI-Onsite #LI-LB1

Job Description As an Account Executive (Mid-Market), you will sell the generative AI SaaS platform for regulatory document creation and workflow management to biotechnology and pharmaceutical companies running 7 to 100 clinical trials. You will be selling primarily to Heads of Regulatory Affairs, Heads of Drug Development, CMOs, and Heads of AI Innovation. The territory is the Southeast United States, with primary focus on the Raleigh-Durham / NC Research Triangle. This is an expansion role reporting directly to the VP of Sales. The base salary is $140,000 – $170,000 USD, plus commissions. COMPENSATION & BENEFITS • • $140,000 – $170,000 USD base salary, plus commissions, • • Year 1 OTE: $280,000 – $340,000 USD (base salary doubled at quota), • • Top performer OTE: $370,000+ (achieved by current top performer within first year), • • Uncapped commission — no cap on earnings; accelerators apply for overachievement, • • Commission paid monthly, • • Stock options, • • Company-paid health, dental, and vision benefits, • • OneMedical, TalkSpace, and Teladoc included, • • 401K matching, • • Laptop provided, • • Clear career advancement path within a fast-growing PE-backed organization THE COMPANY & CULTURE Our client is a venture capital-backed, early-stage SaaS company experiencing 100-200% annual revenue growth. Headquartered in San Francisco, CA, with a team of 35 employees company-wide. The company provides a generative AI platform that creates, reviews, and edits regulatory documents throughout the biotech and pharmaceutical drug development lifecycle. Clients use the platform to shorten regulatory submission timelines, reduce resource requirements for complex filings, and produce higher-fidelity regulatory documents --- addressing a compliance-driven, mission-critical workflow where errors carry significant consequences. OFFICE LOCATION & SALES TERRITORY • • Head Office: San Francisco, California, • • Work arrangement: Remote, • • Sales territory: Southeast United States — primary focus Raleigh-Durham / North Carolina Research Triangle; secondary hubs include Atlanta and Miami, • • Candidate must be located within the Southeast US territory; Raleigh-Durham / Research Triangle, NC, strongly preferred, • • Client-facing work: in-person prospect and customer meetings within territory; up to 50% overnight travel required for prospect meetings, trade shows, and industry events, • • Driver’s licence required — field-based territory role, • • Hours: Monday to Friday, standard business hours; no required evening or weekend client commitments EXPERIENCE, BACKGROUND & EDUCATION REQUIREMENTS • • 3 to 5 years of B2B sales experience with a strong emphasis on SaaS software sales — full-cycle or AE experience required, • • Life sciences industry experience highly desirable — biotech, pharma, CRO, or regulatory consulting; must be able to carry a credible conversation about pharmaceutical drug development and regulatory filing processes, • • Experience selling to VP and Director-level buyers and navigating multi-stakeholder deals (typically 5 decision influencers per deal), • • Familiarity with MEDDIC or a comparable structured sales methodology preferred, • • Driver’s licence required, • • Bachelor’s degree in Life Sciences, Business, or a related field required, • • Knowledge of FDA, EMA, or ICH regulatory guidelines is a plus but not required TECHNICAL SKILLS • • CRM: HubSpot preferred; Salesforce or Tableau also acceptable, • • Sales engagement tools: Salesloft or equivalent, • • Prospecting and enrichment tools: LinkedIn Sales Navigator, ZoomInfo, WIZA, or similar, • • Standard proficiency in Microsoft Office required THE PRODUCT / SERVICE / SOLUTION • • Generative AI SaaS platform for creating, reviewing, and editing regulatory documents used in biotech and pharmaceutical drug development, • • Platform shortens regulatory submission timelines, reduces resource requirements, and improves document fidelity across the drug approval process, • • Sold as a software license (SaaS) PROSPECTIVE CUSTOMERS / INDUSTRY FOCUS / DECISION MAKER(S) • • Mid-market biotechnology and pharmaceutical companies running 7 to 100 clinical trials per year, • • Geographic focus: Southeast United States, primarily Raleigh-Durham / NC Research Triangle and adjacent biotech hubs, • • Primary decision-makers: Head of Regulatory Affairs, Head of Drug Development, CMO, Head of AI for Regulatory, Head of AI Innovation for Drug Development, • • Deals typically involve approximately 5 decision influencers SALES CYCLE / ORDER VALUE / ACCOUNT SIZE • • Average deal size: $100,000 to $1,000,000+, • • Average sales cycle: 6 to 9 months, • • Average number of calls or touches to close: 4 to 6 COMPETITIVE ADVANTAGES • • Purpose-built generative AI platform for a compliance-mandated industry where delays cost millions — not a generic AI tool adapted to regulatory use, • • Demonstrated results with major clients, • • Significant reduction in regulatory submission timelines and resource requirements — a high-value, quantifiable return for buyers, • • PE-backed with aggressive investment in product development and go-to-market growth, • • Low employee turnover and a collaborative, high-performance culture that retains strong AEs TYPICAL DAY & DUTIES • • 100% New Business Development, • On a typical day, you will be conducting outbound prospecting via LinkedIn Sales Navigator, email sequences, and phone outreach to build your own pipeline; engaging executive and senior-level buyers at biotech and pharma companies; running discovery calls, demos, and negotiations; managing your pipeline in HubSpot; and representing the company at industry events and trade shows in your territory. LEADS • • Approximately 75% self-generated through outbound prospecting — LinkedIn Sales Navigator, enrichment tools, email sequences, and phone outreach, • • Approximately 25% from marketing campaigns, webinars, podcasts, and speaking forums, • • No warm book of accounts is provided — this role requires building a pipeline from scratch OVERNIGHT TRAVEL • • Up to 50% overnight travel required, • • Travel is for in-person prospect and customer meetings, trade shows, conferences, and industry events within the Southeast US territory SUPPORT & TRAINING • • Direct reporting relationship with the VP of Sales — 30+ years of sales leadership experience, MEDDIC-focused coaching style, • • Collaborative team environment with 8 existing AEs; culture of information sharing and peer learning, • • Full product and industry onboarding provided, • • Ongoing coaching from the VP of Sales with a structured MEDDIC methodology framework, • • Partnership with Marketing Director on outbound campaign strategy and territory coverage WHY YOU SHOULD APPLY • • Uncapped earnings with no ceiling — the current top performer reached $370,000+ OTE within their first year, • • Open territory with significant upside — the Southeast US / Raleigh-Durham biotech corridor is an underserved, high-growth market, • • Mission-driven product in a high-stakes industry — you are selling technology that accelerates the path to life-saving drugs reaching patients, • • PE-backed company in aggressive growth mode, • • Strong, low-turnover culture under experienced leadership — a VP Sales who coaches to win and invests in the people on his team Equal Opportunity Employer Just Sales Jobs and our clients are equal opportunity employers. We do not discriminate. All candidates are evaluated solely on performance merit and organizational fit. Not the Right Fit? We May Have Other Roles for You. If this particular role isn’t the right match, we encourage you to browse our other open positions at https://justsalesjobs.ca/jobs-opening/ and apply for any that interest you. Our recruiters review every resume we receive — and if we have another role that could be a great fit for your background, we will reach out to you directly

Job DescriptionCompany Description M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance. Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data. Due to our continued growth, we are hiring a Participant Recruitment Manager at Wake Research, an M3 company. This is a remote role. Job Description The Participant Recruitment Manager leads and supports a team of Participant Recruitment Specialists across multiple U.S. research sites, ensuring a consistent and effective approach to study recruitment. This role partners closely with Marketing and Clinical Operations to align recruitment strategy, protocol requirements, and site capacity to achieve predictable, high-quality enrollment outcomes. The position translates recruitment demand into structured operational execution and measurable results. Success in this role requires strong people leadership, operational rigor, and data-driven decision-making. Essential Duties and Responsibilities: • Provide leadership and direct supervision to a distributed team of Participant Recruitment Specialists across multiple research sites., • Drive recruitment and enrollment performance by establishing clear expectations, accountability standards, and measurable outcomes., • Partner closely with Marketing and Clinical Operations to align recruitment strategy with real-time site capacity and study timelines., • Interpret and operationalize clinical study protocols, including inclusion/exclusion criteria and visit schedules, into effective screening workflows., • Develop, maintain, and ensure compliance of patient screeners, qualification scripts, and enrollment processes., • Monitor individual and team performance through KPIs, dashboards, and reporting to support data-driven decision-making., • Identify operational bottlenecks, conversion challenges, and workflow gaps, implementing corrective action plans to improve efficiency., • Provide regular enrollment forecasts, performance updates, and strategic insights to senior leadership while staying current on best practices in patient recruitment and retention.Qualifications, • 5-7+ years of experience in clinical research, including at least 3 years in a management role, • Experience working with CTMS platforms Clinical Conductor/Realtime, Dialpad recruitment tracking systems, and performance dashboards, • Demonstrated success driving participant recruitment and enrollment performance across multiple studies or sites, • Strong understanding of clinical trial processes and inclusion/exclusion interpretation, • Excellent leadership, coaching, and performance management skills, • Strong analytical skills with the ability to translate data into actional operational improvements, • Clear and effective communication across cross-functional teams, • Ability to operate effectively in a fast-paced, metrics-driven environment requiring collaboration across multiple departments and studies., • Proven ability to establish and manage KPIs tied to conversion rates, show rates, and enrollment outcomes Additional Information About M3: M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we’ve seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems. Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements. Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA. Benefits: A career opportunity with M3 Wake Research offers competitive wages, and benefits such as: • 401(k), 401(k) matching, • Dental insurance, • Disability insurance, • Employee assistance program, • Flexible spending account, • Health insurance, • Life insurance, • Paid time off, • Vision insurance *M3 reserves the right to change this job description to meet the business needs of the organization #LI-Remote #LI-LB1

Job DescriptionCompany Description M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance. Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data. Due to our continued growth, we are hiring for a Clinical Research Coordinator II at Wake Research, an M3 company. This position is on-site and located in Raleigh, NC. Job Description The Clinical Research Coordinator II (CRC II) is an experienced research professional who works collaboratively with clinical research site management and the Principal Investigator (PI) to support the successful execution of clinical trials. While the PI maintains overall responsibility for the conduct of the study, the CRC II independently manages and coordinates day-to-day clinical trial activities, ensuring protocol compliance, data integrity, and operational efficiency. The CRC II also serves as a resource and mentor to research staff and contributes to study oversight, workflow optimization, and team development. Essential Duties and Responsibilities: • Assist the Investigator in screening and reviewing potential study participant eligibility in accordance with protocol requirements, • Maintain accurate and timely case report forms, source documentation, study charts, and regulatory documentation, • Provide mentorship, training, and day-to-day oversight to Clinical Research Coordinators and Research Assistants, • Ensure all clinical research activities are conducted in compliance with study protocols, GCP guidelines, sponsor requirements, and applicable laws, regulations, policies, and procedures, • Collect, review, and enter study data with a high degree of accuracy and attention to detail, • Support management in the candidate interview, selection, onboarding, and shadowing processes for new hires, • Assist with study start-up activities, ongoing study maintenance, and close-out procedures across assigned studies and team initiatives, • Collaborate with investigators, sponsors, CROs, and internal departments to facilitate efficient study operations and issue resolution, • Demonstrate the ability to independently prioritize workload and adapt to changing study needs and assignments, • Serve as a resource for team members regarding study processes, protocol requirements, and site proceduresQualifications, • Clinical Research Coordinator with 2+ years of experience, • Phlebotomy experience is highly preferred, • Excellent verbal & written communication skills, • Ability to learn quickly, read and understand complex protocols, follow very detailed directions, and multi-tasking, • Must be able to maintain strict confidentiality of patients, employees, and company information at all times and adhere to HIPAA Guidelines, • Extensive clinical trial knowledge through education and/or experience, • Successful completion of GCP Certification and Advanced CRC preferred, • Detail-oriented, • Familiarity with the Code of Federal Regulations as they pertain to human subject protection, • Strong interpersonal skills Additional Information About M3: M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we’ve seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems. Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements. Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA. Benefits: A career opportunity with M3 Wake Research offers competitive wages, and benefits such as: • 401(k), 401(k) matching, • Dental insurance, • Disability insurance, • Employee assistance program, • Flexible spending account, • Health insurance, • Life insurance, • Paid time off, • Vision insurance *M3 reserves the right to change this job description to meet the business needs of the organization #LI-Onsite #LI-LB1

Job Description Translational Research in Oncology (TRIO) is a global clinical research organization dedicated to advancing cancer research in the clinical trial setting. Our passionate team is committed to bringing cancer treatments of the future to the world of today. We are seeking an experienced physician leader to head our Medical Monitoring Unit, ensuring the medical and scientific integrity of oncology clinical trials across Phase I–III studies. This is a role that goes beyond individual study oversight, requiring the ability to manage people, complexity, and competing priorities within a dynamic and growing portfolio. The ideal candidate brings deep oncology and medical monitoring expertise, combined with strong managerial capability, sound judgment, and the ability to navigate fast-moving, data-rich, and often ambiguous environments. They will balance scientific rigor with operational practicality, communicate effectively across stakeholders, and lead with a high level of ownership, credibility, and strategic perspective. Reporting directly to the Vice President, Medical Affairs, this position offers a remote or hybrid work model, depending on the candidate’s location and preference. Key Responsibilities • Lead, manage, and further develop the Medical Monitoring Unit, including direct oversight of multiple Medical Monitors, • Ensure consistent, high-quality medical monitoring across oncology trials from Phase I through Phase III, • Provide expert medical guidance on protocol interpretation, safety events, eligibility, and benefit-risk assessment, • Act as a senior medical point of contact for sponsors, investigators, and internal stakeholders, • Drive consistency, quality standards, and best practices across studies and across the team, • Manage resource allocation and priorities across a complex and evolving study portfolio, • Contribute to study and portfolio-level planning, including alignment with budgets and cross-functional collaboration, • Support hiring, coaching, and retention of high-performing medical staff, • Partner closely with cross-functional teams including Clinical Operations, Drug Safety, Medical Writing, and RegulatoryQualifications, • Medical Doctor (MD) required; oncology specialization strongly preferred, • 8 – 10+ years of experience in clinical research, • Proven experience as a Medical Monitor in oncology clinical trials (Phase I–III), • Strong background in safety review and medical decision-making in active oncology studies, • Demonstrated experience in people management and team leadership, • Experience managing multiple studies or programs simultaneously, • Strong understanding of clinical trial design and regulatory frameworks (ICH-GCP, FDA, EMA), • Fluent English required; Spanish is a plus, • CRO experience strongly preferred; Pharma experience will also be consideredWhat TRIO Can Offer You, • Opportunity to lead a critical function within an oncology-focused organization, • High-impact role with visibility across senior leadership, • Exposure to a diverse and scientifically meaningful oncology portfolio, • A role combining medical depth, leadership responsibility, and strategic influence, • Annual compensation review with opportunities for professional growth, • 3 weeks of vacation plus paid December Holiday Closure, • 10 days paid personal/sick time, • 1 paid volunteer day / year, • A top tier, comprehensive Health / Medical plan for you and your family – Monthly premiums paid for by TRIO, • Up to 5% matching 401(k) Program, • Flexible working hours to promote work-life balance, • Monthly Internet Allowance to support working from home, • Remote work arrangements anywhere across the USA and receive a one-time home office allowance, • Out-of-country Work: Employees can request to work internationally for a short period of time each year, • Employee Family Assistance Program to support you and your family during difficult times, • Employee Recognition Program to reward long-term employees, • Employee Referral Bonus ProgramPay Range: $150,000 to $200,000 USD - Salary to be influenced (or determined) by the education, experience, location, knowledge, skills, abilities of the applicant, internal equity, and alignment with market data. If you are interested, please submit your resume in English. We thank all candidates for their interest; only those selected for an interview will be contacted. Prior to applying please review TRIO's Applicant Information Notice To support efficiency, TRIO may use limited AI tools during the candidate review process. All hiring decisions are made by people, not AI. To ensure fairness and an accurate understanding of your skills, we ask that candidates refrain from using AI tools or AI‑generated responses during interviews or assessments. We want the opportunity to get to know you and your experience. Teamwork · Passion · Integrity · Innovation Powered by JazzHR TE3i2mFWwn

Job DescriptionCompany Description M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance. Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data. Due to our continued growth, we are hiring for a Clinical Operations Lead at Wake Research, an M3 company. This is a remote position with up to 50% domestic-travel. Job Description The Clinical Operations Lead is responsible for driving the successful execution of clinical trials across multiple sites and priority programs. This role ensures studies meet enrollment targets, quality standards, and sponsor/CRO expectations throughout the study lifecycle. The Clinical Operations Lead serves as a central point of coordination between sites, sponsors, CROs, and internal teams, proactively identifying risks, removing barriers, and maintaining alignment across stakeholders. This individual plays a hands-on leadership role, in collaboration with the Site and Regional Director, in optimizing site performance, supporting operational excellence, and ensuring consistent, high-quality study execution across the network. This role requires up to 50% travel. What You’ll Do: • Serve as the primary operational lead for assigned studies, with accountability for enrollment performance, study quality, and overall execution across multiple sites, • Partner with sponsors and CROs as a key point of contact, ensuring clear communication, alignment on expectations, and proactive management of study needs and concerns, • Work directly with site teams to monitor enrollment progress, identify barriers to recruitment, and implement targeted action plans to improve performance, • Proactively identify operational risks, including enrollment challenges and protocol-related issues; develop and execute mitigation strategies to keep studies on track, • Drive accountability across sites by tracking and managing key performance indications (KPIs), including enrollment, screen failure rates, data quality, and timelines, • Lead and facilitate study-related meetings with internal teams, sites, and sponsors/CROs, including kick-off meetings, enrollment reviews, and ongoing operational calls, • Ensure timely and effective communication across all stakeholders, providing clear updates on study status, risks, and performance, • Support study start-up, amendments, and ongoing trial execution by coordinating across functional teams to ensure efficient and compliant processes, • Maintain accurate and up-to-date tracking of study timelines, milestones, and performance metrics within internal and external systems, • Collaborate with Clinical Operations leadership to identify process improvement opportunities and implement solutions to enhance efficiency, quality, and site performance, • Provide hands-on support to sites as needed, including onsite engagement, to address operational challenges and improve execution, • Support the rollout and adoption of new processes, tools, and technologies that enhance clinical trial delivery Qualifications Education and Training Required: • Associate degree (2-year program) or equivalent level of education required; Bachelor’s Degree (4 year program) in a related field preferred Minimum Experience: • 5 years or more of clinical research experience within a Clinical Research Site/Network or Contract Research Organization (CRO), • Experience as a Clinical Research Coordinator and/or Clinical Research Associate preferred Knowledge, Skill, Ability: • Understanding of clinical research process and pharmaceutical development lifecycle, • Experience with Salesforce, RealTime CTMS, eSource and eDocs or other CTMS and eRegulatory platform preferred, • Excellent oral and communication skills, • Mastery skills in Microsoft Word, Excel, and/or other data management tools, • Understanding of clinical and site logistics, as well as study start-up and site activation, • Strong understanding of multi-site clinical trial operations, including enrollment strategies and site performance management, • Excellent written and verbal communication skills, with the ability to engage effectively with sites, sponsors, and CROs, • Proven ability to manage multiple priorities and drive results in a fast-paced environment, • Strong problem-solving skills with a proactive, solution-oriented mindset, • High attention to detail with a focus on quality and compliance, • Ability to influence and lead cross-functional and multi-disciplinary teams without direct authority, • Strong organizational and time management skills, • Demonstrated ability to identify inefficiencies and implement process improvements, • Supports team growth and hiring efforts as needed Additional Information About M3: M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we’ve seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems. Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements. Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA. Benefits: A career opportunity with M3 Wake Research offers competitive wages, and benefits such as: • 401(k), 401(k) matching, • Dental insurance, • Disability insurance, • Employee assistance program, • Flexible spending account, • Health insurance, • Life insurance, • Paid time off, • Vision insurance *M3 reserves the right to change this job description to meet the business needs of the organization #LI-Remote #LI-LB1

Job DescriptionCompany Description Ergomed PLC is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease. Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America, and Asia. Our company allows for employee visibility (you have a voice!) creative contribution and realistic career development. We have nourished a true international culture here at Ergomed. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved. Come and join us in this exciting journey to make a positive impact in patient’s lives. Job Description Responsibilities: The Clinical Team Manager will be responsible for operational project management The CTM proactively identifies, resolves/mitigates, and escalates risks and/or issues to the PM/PD and Head of Clinical Operations as necessary Verifying and ensuring that project team members (CRAs, Site Managers, CTAs) are trained (e.g., GCP, SOP, indication, protocol, study specific procedures / requirements, etc.) to perform their assignments Developing, reviewing and revision of project documents (e.g., monitoring plan, CRF completion guidelines, study specific operating manual, study specific forms etc.) Initiating corrective / preventative measures – e.g., update of study guidance documents, performing re-training, performing co-monitoring, etc. Qualifications Extensive clinical research lead experience in multiple studies Experience in managing Clinical part of studies in more than one region or equivalent study complexities Experience of phase 2/3 trials, ideally complex studies such as oncology or rare disease Able to work in a fast-paced small CRO environment and manage multiple projects A minimum of a science-based bachelor’s degree Able to work effectively with minimal supervision Additional Information Why Ergomed We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow. To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us. We offer: Training and career development opportunities internally Strong emphasis on personal and professional growth Friendly, supportive working environment Opportunity to work with colleagues based all over the world, with English as the company language Our core values are key to how we operate, and if you feel they resonate with you then Ergomed is a great company to join! Quality Integrity & Trust Drive & Passion Agility & Responsiveness Belonging Collaborative Partnerships We look forward to welcoming your application.

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