Senior Clinical Operations Lead
DUTIES – RESPONSIBILITIES
The Sr. Clinical Operations Lead (COL) leads the planning, execution and conduct of complex clinical programs while adhering to budget, scope and timelines. The Sr. COL is responsible for managing all aspects of multiple clinical trials with emphasis on CRO & vendor management to drive a high functioning and results-driven team including timeline adherence, patient safety, adherence to contracted deliverables, the protocol(s) and appropriate regulations and data integrity. The Sr. COL 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.
The major functions to be performed in this position are as follows:
• Serve as primary Operations contact for internal and external study team members on assigned studies/projects and as 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 with clear roles, responsibilities, and communication pathways. Plans and processes may be developed in collaboration with CROs and/or vendors including but not limited to plans for vendor oversight, project management and communication, recruitment, monitoring, risk management to ensure studies are conducted efficiently, effectively and in accordance with the protocol, GCP/ICH guidelines, FDA 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 Meetings & Trainings, Investigator Meetings, Scientific Meetings.
• 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.
• May participate in mentoring junior staff.
• Performs other duties as assigned.
• Education: Bachelors’ degree in science or nursing. Masters’ degree (MBA, MS or MPH) or PMP certification required.
• Experience: Minimum of 10 years of clinical research experience. Vendor management experience is required. Experience with monitoring oversight or direct monitoring required.
• Preferred: Experience with oncology and/or radiopharmaceuticals preferred.
• 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 is required.
• Experience in clinical program management, and clinical operations management of clinical trials
• Well organized and detail oriented with strong written and verbal communication skills.
• Proficient in MS Office applications