Clinical Operations Director for Clinical Trial Management
7 days ago
About the Role
We are seeking an experienced Clinical Operations Director to lead our clinical trial management team. The successful candidate will be responsible for planning, executing, and conducting complex clinical programs while adhering to budget, scope, and timelines.
Key Responsibilities
- Provide leadership to study teams and make recommendations in strategic aspects of clinical programs
- Lead the creation of initial study budgets with input from cross-functional leads and act as the primary point of contact with finance and leadership team throughout the life of the study.
- 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
- 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
- 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
- Continuously assess risks to study performance, timelines, budgets and proactively plan risk mitigation strategies
- 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
- Lead quality reviews of study conduct, including TMF and monitoring report reviews, and lead inspection readiness activities for both internal sponsor audits and health agency audits (FDA, Health Canada, etc)
- Perform ongoing assessment of operational efficiency and communication and adjust study processes to ensure high team performance
- Review and/or write SOPs for Clinical Operations and Clinical Development, update and maintain SOPs, and participate in departmental improvement initiatives
- Direct or indirect management and oversight of CTA and/or junior COLs
- Contribute to management decisions on project team resourcing needs and strategy
- Perform other duties as assigned
Requirements
- Bachelors' degree in science or nursing
- Minimum of 10 years of clinical research experience, with minimum of 6 years trial management experience in industry (sponsor or CRO) At least 5 year of vendor management experience is required. Experience with oncology, neurology and/or radiopharmaceuticals required
- Preferred: Masters' degree (MBA, MS or MPH) or PMP certification. Experience with monitoring oversight or direct monitoring preferred.
Salary
The estimated salary for this position is $120,000-$150,000 per year, depending on qualifications and experience.
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