The Senior Clinical Trials Manager, Clinical Operations, combines end-to-end design, execution, and reporting of oncology clinical trials with leadership in study teams and across matrix teams.
Requirements
- Accountable for the global study delivery strategy
- Drive assessment, selection, engagement, management, and oversight of appropriate vendors
- Ensure compliance with ICH/GCP guidelines, all applicable laws, and regulations, and Exelixis SOPs
- Make decisions which balance risk/benefit with clear understanding of impact on the study and project
- Prepare materials for internal governance and / or financial review cycles
- Actively partner to build relationships and collaborate with aligned staff in other functions
- Encourage others within matrix and line teams to seek alternative perspectives and develop solutions
- Lead and conduct investigator meetings and other study related meetings and participate in governance meetings, as necessary
- Identify and communicate resource gaps for assigned studies
- Lead risk management and quality efforts to ensure study compliance and continual inspection readiness
- Lead / contribute to ways of working and process improvement initiatives
- Provide expert clinical operational input into protocol development
- Partner with Data Management and Clinical Sciences to develop the data cleaning strategy for the study
- As the SDL, lead the SDT and actively partner to build relationships and collaborate with SDT functional members
- Work with the appropriate functions to develop patient centric documents and address patient burden
- Contribute to and engages Clinical Operations staff in process development, innovative problem solving, training initiatives as needed
- Provide proactive and consistent oversight of CRO and vendor performance
- Support Clinical Operations Program and / or Indication Lead with key study level status updates, with a particular focus on delivery to corporate and project level objectives
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Health, Dental and Vision Coverage
- Life and Disability Insurance
- Flexible Spending Accounts
- Discretionary Annual Bonus Program
- Sales-Based Incentive Plan
