Description
The Associate Medical Data Review Manager is a key member of the Global Medical Review Team, responsible for executing Central Medical Review activities within the Central Monitoring strategy.
The successful candidate will collaborate with cross-functional teams to ensure effective execution of Central Monitoring plans, prepare and conduct Central Medical Review tasks, and provide support to the study team and clients.
Summary of Responsibilities:
- Collaborate in the development of Central Monitoring proposals and contribute to proposal strategy
- Support Sponsor presentations and bid defenses
- Ensure timely and accurate tracking and status reporting
- Apply data to identify patient safety concerns and evaluate safety signals
- Contribute to the Risk Assessment and Categorization Tool and Xcellerate Medical Review configuration
- Support data experts with critical data and process definition
- Develop medical review requirements and design visualizations
- Draft and finalize Central Medical Review Configuration Plans and Central Monitoring plans
- Manage Xcellerate Medical Review tool configuration and perform user acceptance testing
- Perform ongoing Central Medical Review and discuss findings with Project Physicians
- Provide data-driven decisions and communicate findings proactively to stakeholders
- Take responsibility for inspection readiness and support regulatory authority inspections
- Collaborate with other Central Monitoring activities to ensure consistency and effectiveness
- Evaluate and collate process improvement suggestions and submit to leadership
- Provide training and mentoring to new team members
Qualifications (Minimum Required):
- Medical doctors, allied medical degrees, post-graduation in life sciences, or applicable qualifications
- Relevant and equivalent experience may be considered in lieu of educational requirements
Experience (Minimum Required):
- Relevant experience, exact requirements not specified
Physical Demands/Work Environment:
- Standard office or home working equipment required
- Minimal travel required