Senior Clinical Data Manager
San Carlos, CA
This is an onsite contract position in the San Francisco, Bay Area.
The Clinical Data Manager (DM) is responsible for the coordination and delivery of Data Management contracted services on assigned projects. This includes meeting internal and external sponsor requirements according to time, quality, scope and budget parameters. The DM is the primary point of contact for Data Management on a project, for internal project team members, sponsors, and external data vendors. The DM presents project-related training and may provide technical guidance and direction to team members.
Specific Tasks Include:
- Serves as the primary Data Management interface for internal project team members, sponsor representatives, third-party CROs, and external data vendors.
- Ensures the timely initiation, conduct, and completion of Data Management activities on clinical trials.
- Leads a sub-team of Data Management staff members assigned to a project.
- Tracks Data Management timelines for assigned projects and ensures that all applicable Data Management team members are aware and on target for deliverables.
- Authors of the Data Management Plan (DMP), outlining all data management responsibilities.
- Authors of the Data Transfer Agreement (DTA) with third-party external data vendors
- Oversees UAT of clinical data systems (EDC, eCOA, IWRS) to be implemented on a project.
- Conducts project-specific training throughout the course of the project, as needed.
- Attends and presents at client bid defense meetings.
- Attends and presents at project meetings as required.
- Oversees the completion of a comprehensive data review of clinical data.
- Ensures medical coding is performed in a timely manner
- Ensures DM documentation is audit-ready and filed appropriately at all times.
- Coordinates all activities in preparation for database lock, including Data Review Meeting.
- Produces status or progress reports, listings, and other output as required during the course of the project
- Monitors budget and scope of work for contracted DM services throughout the duration of the project, identifying out of scope or budget activities, and collaborating with the project manager when out of scope documentation and costs are needed.