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Clinical Operations Director
2 months ago
Job Summary
The Director of Clinical Operations is responsible for leading the development of a Clinical Operations Team in the United States. This role will work closely with the Function Head to plan and assign resources across studies.
Key Responsibilities
- Team Leadership
- Lead a team of Project Managers, Clinical Research Associates (CRAs), and Clinical Trial Associates (CTAs)
- Mentor, motivate, train, and oversee team members
- Operational Management
- Oversee and manage all operational aspects of phase I-IV US-based or global clinical trials
- Act as primary point of contact for internal and external teams for planning, conduct, and reporting of assigned trials
- Vendor Management
- Participate in vendor selection process with assigned PMO representative
- Develop and review proposals, bid-defense processes, and contract reviews
- Study Start-Up
- Oversee study start-up activities of CROs (e.g., site identification, feasibility, site selection, contract negotiation, and clinical study agreement finalization)
- Manage and assess vendor performance (timelines and deliverables)
- Financial Management
- Prepare and review budgets for studies managed in-house and review professional fees and pass-through costs for CROs, SMOs, investigators, and vendors
- Manage and track study budgets, project milestones, and timelines throughout the life of the study
- Quality Assurance
- Develop and implement quality control plans in assigned studies
- Ensure clinical studies (in-house or outsourced) are in compliance with ICH-GCP, SOPs, and applicable regulations
- Communication and Collaboration
- Coordinate with cross-functional groups for required deliverables
- Provide status updates to stakeholders as per project requirements
- Process Improvement
- Lead process initiatives and improvements as assigned by the Function Head
Secondary Responsibilities
- Perform/Assist during audits/assessments
- Participate in meetings and discussions with CROs and support teams
- Manage managers and resources performing lead activities
- Contribute to interview processes
- Contribute to Clinical Development Strategy
- Participate in conferences and workshops
Requirements
Education and Qualification
Bachelor of Science in a life sciences discipline, or higher qualification
Experience
10+ years of clinical trial experience
