Description
Qualified candidates will possess the following experience:- 5+ years prior pharmaceutical or biotech sponsor company experience
- Independent phase III clinical study management
- Oncology (or other complex indication)
- Minimum 1 year CRO management experience
- Minimum 1 year experience managing direct reports
- International clinical study experience
- Ability to meet aggressive timelines
- Budget management
- Bachelors Degree
Primary Responsibilities include:
- Provides direction and leadership to global Phase III oncology clinical trial(s)
- Develops operational plans including site monitoring strategies, trial budgets, site selection, and clinical supplies management
- Provides the day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work
- Oversees the development and maintenance of study specific manuals
- Contributes to the development and management of the study timelines, resources, and budgets
- Ensures operational tracking tools are identified, including systems to meet the needs of the operations team and ensures reporting to the Senior Director, Clinical Operations
- Ensures accurate tracking and reporting of study metrics
- Provides operational input into the development of protocol feasibility questionnaires
- Provides clinical operations expertise to ensure operational feasibility and delivery
- Participates in the forecasting and management of non-clinical supplies to ensure sites have supplies to run clinical study
- Coordinates with Regulatory Affairs to prepare responses to study questions or issues from Health Authorities or IRBs/IECs
- Performs ongoing vendor management (e.g., CROs, Central Labs, IVRS, Reading Centers), including independent negotiation of scope of work, budgets, performance management, and issue resolution
- Ensures study adherence to ICH/GCP and SOPs