Clinical manager
The Senior Clinical Trial Manager coordinates the activities associated with the evaluation, initiation, and management of clinical trials. This position is responsible for overseeing the execution of clinical trials, collaborating with cross-functional teams, performing oversight activities of Contract Research Organizations (CROs), and providing operational support to the Study Delivery Lead (SDL).
Specific Tasks- Manage clinical trial activities for assigned programs ensuring compliance with ICH GCP, US FDA, EMEA and applicable regulations; may lead the development of all study-related plans necessary for trial conduct.
- Manages clinical trials, including those conducted through Contract Research Organizations (CROs
- May participate in developing and recommending operational strategies for clinical trials in collaboration with cross-functional teams
- Responsible for at least one geographical region and manages/oversees one to three external vendors within a specific scope (e.g., Lab)
- Engages with CROs, vendors and sites for ongoing trial execution, including relationship management and quality / performance oversight
- Provides CRO oversight on activities related to site start-up and maintenance, including reviewing trip reports, protocol deviations, data review, etc.
- 10+ years Clinical Research Experience
- 5+ yrs of recent Global Oncology Clin Ops Exp -- doing Vendor Oversight Trial Management
- Willingness to travel up to 20% in the US
- BS/BA/BSN in Biological Sciences or related field
- Strong team player; ability to work within a national/remote team.
- Flexibility and successful history in managing workload that spans across multiple time zones
- Eagerness to learn and grow within the role
- Ability to pivot quickly to manage competing priorities in a fast paced environment
- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)
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