About the Role
The Clinical Data Manager will lead data management activities for clinical studies, ensuring data integrity and adherence to protocols, regulatory standards, and project timelines.
Responsibilities
- Design and manage clinical data collection instruments and databases
- Develop data management plans and validation rules
- Oversee data entry, cleaning, and query resolution processes
- Ensure data quality through audits and validation checks
- Collaborate with cross-functional teams on study execution
- Support electronic data capture system setup and testing
- Generate data discrepancy reports and track resolutions
- Coordinate with external vendors and CROs on data deliverables
- Maintain data management timelines aligned with study milestones
- Prepare data for statistical analysis and regulatory submissions
- Ensure compliance with SOPs, GCP, and regulatory requirements
- Train team members on data management procedures
- Review case report forms and data collection tools
- Manage database lock and archival processes
- Participate in study protocol and CRF development
- Lead data review meetings with project teams
- Troubleshoot data system issues with IT and vendors
- Document data management processes and changes
- Support inspection readiness and audit responses
- Monitor data timelines and escalate risks as needed
Compensation
Competitive salary and benefits package offered
Work Arrangement
Hybrid work model available
Team
Part of a global clinical operations team
Preferred Qualifications
- Advanced degree in a relevant scientific field
- Experience with adaptive trial designs
Technology Skills
- Hands-on experience with Medidata Rave or Veeva
- Familiarity with clinical data interchange standards
Sponsorship available for qualified candidates
