Clinical Operations Lead
24 hours ago
Rockville
Who We Are: Ascentage Pharma: (Nasdaq: AAPG and HKEX: 6855) is a global, clinical-stage biotechnology company engaged in developing novel therapies for cancers and other diseases. Ascentage Pharma is proud of its collaborative, supportive culture, unified by the desire to develop therapeutics that will have a positive impact on patients’ lives. Ascentage Pharma is a dynamic and fast-paced organization that has been responsive to the needs of individual employees throughout its history. The company is defined by a shared understanding it succeeds in advancing its mission only as each individual experiences’ success in their role. Leveraging our robust internal research and development capabilities, we have built a portfolio of global intellectual property rights. We have also established global collaboration relationships with leading biotechnology and pharmaceutical companies, such as AstraZeneca, Innovent, Merck, and Pfizer and research and development relationships with leading research institutions, such as Dana-Farber Cancer Institute, Mayo Clinic, MD Anderson Cancer Center, National Cancer Institute and the University of Michigan. We are a leader in global innovation with a portfolio of more than U.S. and international patents and more than U.S. and international pending applications. We have assembled a talented, global team with experience in the research and development of innovative drugs, as well as commercial manufacturing, sales and marketing. Our success is shaped by this global team of over to 700 employees across United States, Europe, Australia, and China. Job Description Summary: The Clinical Operations Lead (COL) is responsible for supporting the Clinical Trial Manager/operational team in execution of the trial (s). The function could include direct liaison with CROs and other ancillary vendors, as appropriate, to manage relevant trial(s) operational tasks. Maintain effective communication with project team through oral and written correspondence, status reports to ensure alignment with study timelines. Works under general supervision. Primary Duties and Responsibilities • Assists in the review, development and writing of clinical trial documents and manuals, including but not limited to study manuals, laboratory or biomarker plans, and other supporting documents., • Create Master ICF template and review/approve site changes (in consultation with legal, safety when warranted). Update template for new risks and new amendments information., • Participate in the feasibility and evaluation of investigative sites; working closing with the Clinical Trial Manager., • Coordinate and monitor activities at investigational sites; review monitoring trip reports and support the US monitoring organization., • Assist in the development and management of study timelines and priorities, including recruitment tools/strategy and patient retentions plan., • Plan and organized meetings with team support (eg. investigator/coordinator meetings, DMC, SMC, safety call, etc.)., • Assist in the development of the IP and co-medication strategy (Quantities, labels, depots, tracking, etc.) working closely with other departments., • Participate in data review and discrepancy resolution., • Participate in coordinating efforts with internal Pharmacovigilance, and safety group., • Monitor study-specific timelines and key deliverables; focus on management of all external vendors (e.g Monitoring, Sample management, IVRS, Laboratory, etc)., • Participate as a member of the multi-disciplinary trial(s) team., • Develop relationships with investigational sites and institutions to enhance conduct of the trial., • Acts as preliminary liaison for study sites to convey trial information, answer questions and act in accordance with the escalation established pathway., • Assume responsibility to participate as a member of a working group and perform special projects, as assigned, to improve the efficiency, effective and quality of the functioning of the Development Operations Department., • Contributes to the development of RFPs and participates in the selection of CROs/vendors. Manages CRO and vendor activities to ensure adherence to deliverables and timelines. May train CROs, vendors, investigators, and study coordinators on study requirements. Maintains frequent and meaningful contact with CROs to assess performance and provide guidance as needed., • Proactively identify project issues and risks and resolve with minimal supervision, • Maintains and reviews study timelines (including recruitment), • Contributes to the development of study budget(s), • Track, monitor, and routinely report/present clinical site/study progress, • Ensures the ongoing compilation and reconciliation of the Trial Master File (TMF) so that clinical trial(s) is “audit-ready” at all times. Ensures that any audit observations are addressed appropriately and promptly., • May provide leadership and guidance to other clinical operations staff members (PCs), • Complies with all applicable policies regarding health, safety, and environmental policies, • Performs other duties as requested Knowledge/Skills/Abilities Required The minimum level of education and years of relevant work experience: • Bachelor’s or master’s degree in nursing, life science, or related field, or equivalent education/training, • At least four (4) years of clinical trial/clinical operations experience with at least three (3) years of experience in clinical project management in a biopharmaceutical organization or equivalent, • Strong project management skills with the ability to deliver results on schedule in a fast-paced,, • entrepreneurial environment, • Recent experience in oncology phase 1-2 trials is preferred, • Previous clinical monitoring experience is desired, • Previous experience negotiating vendor/site contracts and managing the budgets, • Solid vendor management skills, e.g., CRO, Laboratory, Clinical supply logistics, • Experience with insourced and outsourced studies is preferred, • Thorough knowledge in clinical research operations, including FDA and EU regulations, GCP/ICH guidelines, • Applies best practices to the clinical trial process, • Working knowledge of IND safety reporting, • Strong attention to detail and accuracy, timeliness, self-motivation, developed organizational skills, and ability to work both as part of a team and independently, • Substantial problem solving and analytical skills and identifies issues and problems and formulates potential solutions proactively, • Demonstrated communication skills, including presentation and writing skills. Demonstrated positive interpersonal skills; ability to actively maintain good professional relationships., • Displays strong leadership skills, • Ability to effectively interface with medical personnel at clinical sites, • Ability to lead multi-disciplinary, cross-functional teams both internally; externally, • Ability to write and edit technical documents, such as protocols, protocol amendments, informed consent, and other trial-related documents, • Demonstrated ability to handle several priorities within multiple, complex trials, • Demonstrated ability to work productively in a matrix team environment in a growing and changing environment, • Knowledge of electronic data capture including basic data processing functions, • Knowledge of TMF maintenance and management of essential documents, • Computer skills including high proficiency in the use of a laptop computer and Microsoft Office Suite: Outlook, Word, Excel, and PowerPoint Job Location Preference for applicants located on the East Coast Compensation and Benefits Ascentage Pharma offers a highly competitive compensation package, including an annual bonus and a comprehensive benefits package that includes: • Medical, Dental, and Vision Insurance Ascentage also offers: • Life Insurance, Spouse Life Insurance, Critical Illness, Company Paid Short-and Long-Term Disability (STD & LTD), Voluntary Accident Insurance, Identity Theft, and Pet Insurance, • 401K Retirement, with generous company match, • We have a liberal Paid Time Off Policy, • Flexible Schedules for all staff, EAP Culture At Ascentage Pharma, we strive to create a culture based on personal and professional growth and opportunity, focusing on these principles: • Establish a collaborative, energized, and fun work environment where people are empowered and supported in the achievement of their career goals. Working at Ascentage allows you to balance your priorities., • Create a diverse and multi-disciplinary workforce where all levels within the organization are empowered to lead, welcomes innovation, and supports your career goals, • Hire dedicated, talented, and entrepreneurial people who are passionate about achieving excellence in all they do every day, have a commitment to science and to the patients we serve.