Contract – Clinical Data Manager II
SF Bay, California
Role and Responsibilities
- Work concurrently on multiple data management projects, with minimal guidance from a line manager or experienced
- Assist in reviewing/writing/editing sections of the Data Management Plan and eCRF Completion Guidelines at the direction of the Project Data
- Support User Acceptance Testing (UAT) for validation (edit) programs as requested.
- Independently perform additional data cleaning tasks which include logic checks using listings and reports as
- Generate data complex data queries as directed by Manager/Project Data Manager with minimal guidance.
- Reconcile project files, reports, listings and other documents generated in data management against a database for accuracy and completeness of data management
- Perform all tasks to relevant SOPs, ICH or other regulatory guidelines in Data
- Perform other duties as required by the
Associate/Bachelor degree in biological science or a related discipline
Minimum 5 years of experience in clinical data management at a sponsor and /or CRO.
- Good knowledge of all technical elements of Data Management
- Understanding of ICH-GCP principles
- Good knowledge of medical terminology and clinical research terminology
- Demonstrated ability to provide coaching and training to new hires and less experienced colleagues
- Effective written and verbal communication
- Manages time effectively to produce quality deliverables in the expected timeframe