We're a biopharmaceutical company developing innovative cancer immunotherapies. We're looking for a Manager, Clinical Data Management to lead cross-functional teams and support our efforts in clinical data management.
Requirements
- Lead the management of CDM deliverables in coordination with internal and external cross-functional teams
- Provide CDM expertise for data coordination, collection, and cleaning
- Develop and manage data management timelines to ensure study goals and activities are met
- Oversee External Data Management activities
- Anticipate obstacles and difficulties of stakeholders and staff and acts upon them or escalates accordingly
- Manage the development and finalization of CDM documents
- Review and manage the eTMF for completeness and accuracy
- Serve as a primary point of contact for internal and external study team members
- Ensure completeness, accuracy, and consistency of clinical data and data structure
- Responsible for data review, query management, and metric report delivery to study teams
- Coordinate study timelines and database snapshots for analysis and safety review meetings
- Participate in and/or represent CDM during internal audits as well as Health Authority audits and inspections
- Participate in the development, review, and implementation of processes, policies, SOPs, and associated documents affecting CDM
Benefits
- Paid time off
- Benefits package
- Company-sponsored medical, dental, vision, and life insurance plans
- Discretionary annual bonus
- Discretionary stock-based long-term incentives