My oncology pharmaceutical client with late phase, ongoing studies is seeking a home based/remote Senior level Clinical Trial Manager (Sr CTM) to lead the planning, execution and conduct of complex clinical studies while adhering to budget, scope, and timelines.
Home-based in the New York City Metro Area (NY, NJ, or CT), the Sr. CTM is responsible for managing all aspects of multiple clinical trials with emphasis on CRO and vendor management to drive a high functioning and results-driven team including timeline adherence, patient safety, adherence to contracted deliverables, the protocol(s), appropriate regulations, and data integrity.
The Senior CTM is expected to provide leadership within the department and to make recommendations with regards to the strategic aspects of Clinical Operations deliverables, timelines, budgets, and resourcing.
- Location: Home-based in the New York City Metro Area (NY, NJ, or CT); 100% remote position
- Education: Bachelor’s degree in science or related field; advanced degree preferred.
- Late phase (Phase II or III) Clinical development experience with trial management experience in industry (sponsor or CRO) is required.
- Vendor management experience is required.
- Oncology and/or radiopharmaceuticals is required.
- Experience or a desire and ability to work for a smaller biopharma within a small clinical operations team on complex late phase studies as a permanent employee.
- Previous or current experience as a Monitor &/or monitoring oversight experience.
- Other Requirements • Possess highly effective interpersonal and analytical skills enabling influencing and negotiation skills • Strong problem solving and decision-making skills • Strong understanding of clinical trial methodology, drug development process, ICH-GCP guidelines and applicable regulatory requirements • Well organized and detail oriented with strong written and verbal communication skills • Proficient in MS Office applications
Key Responsibilities / Essential Functions • Serve as primary Operations contact for internal and external study team members on assigned studies/projects and as the escalation point for investigators and sites. • Lead the selection of CROs, consultants, and vendors including identifying potential vendors and developing proposal requests. • Contribute to management decisions on project team resourcing needs and strategy. • Establish and continuously monitor/update the global study timelines and budgets, including all internal functional areas, vendors, CROs, and promptly escalating significant risks or changes. • Oversee CRO and/or vendor activities and coordinate cross-functional department activities to successfully achieve milestones and quality deliverables in study management, including but not limited to site selection, study start-up, recruitment, study conduct, and database lock and study close-out. • Lead cross-functional development of and adherence to study specific operational plans, and processes ensuring clear roles, responsibilities, and communication pathways. Plans and processes may be developed in collaboration with vendors including plans for vendor oversight, project management, communication, recruitment, monitoring, and risk management. These will ensure studies are conducted efficiently, effectively, and in accordance with the protocol, GCP/ICH guidelines, federal regulations, and applicable SOPs. • Contribute to development of plans and documents led by other functions such as data management and data review plans, statistical analysis plan, safety management plan, etc. • Track and report on the overall status of assigned clinical trials including enrollment metrics, key performance indicators (e.g., deviations, trial risks, monitoring metrics), milestones, timelines, and budgets. • Organize and participate in meetings, i.e., Study Team, Trainings, Investigator, and Scientific. • Review and/or directly contribute to study documents such as vendor specifications, study manuals, training materials, site and patient facing materials, CRFs, monitoring reports, special correspondence, communication plans, etc. • Contribute to protocols, clinical study reports, annual reports, key safety reports, and regulatory documents. • Perform ongoing assessment of operational efficiency and communication and adjust study processes to ensure high team performance. • Review and write SOPs for Clinical Operations, update and maintain SOPs, and participate in departmental improvement initiatives. • Mentor junior staff as needed. • Perform other duties as assigned.