Contract to Perm Lead Clinical Data Manager | San Carlos, CA
||Lead Clinical Data Manager
|| San Carlos
||Clinical Data Management
||Contract to Perm
Role and Responsibilities
- Responsible for all data management tasks from start-up to database close-out.
- DM lead for internal and external team meetings and communication.
- Serve as the data management expert for assigned projects.
- Coordinate the work of both internal and external team members.
- Anticipate roadblocks and provide practical solutions.
- Track project progress and issue status report.
- Oversee initial and post go-live database development
- Creates and Maintain CDM Documentation:
- Data Management Plan,
- CRF Completion guidelines,
- Edit specifications,
- Reconciliation guidelines,
- Data Review Plan,
- DM listings, and
- Report specifications.
- Assist in the creation and documentation of new or revised procedures.
Bachelor degree in biological science or a related discipline in the science/healthcare field or equivalent education.
Minimum 8+ years of experience in CDM or Biostatistics in a CRO or pharmaceutical industry, or an equivalent combination of education and experience to successfully perform key responsibilities of the job.
- Thorough knowledge of all technical elements of data management.
- Understanding of ICH-GCP principles.
- Thorough understanding of medical terminology and clinical research terminology.
- Varied therapeutic area experience.
- Demonstrated ability to provide coaching and training to new hires and less- experienced colleagues.
- Communicates effectively through both written and verbal methods.
- Manages time effectively to produce quality deliverables in the expected timeframe.