- Ensure that the Data Management group is aligned with business objectives and complies with FDA requirements.
- Contribute to development of outsourcing strategies and relationships with outsourcing partner and play a key role in identification of quality DM partners including coordinating the review and approval of the Master Services Agreement.
- Manage the clinical data managers within the organization.
- Work closely with CROs to prepare and ensure proper execution of data management plans; manage data management projects from beginning to end.
- Work closely with Medical Directors, Medical Monitors, CTAs, and CRAs in planning and execution of DM activities regarding clinical studies.
- Coordinate with biostatisticians, data managers, CRAs, programmers, etc., to expedite and assure the flow of data between study sites, the data management group.
- Prepare and distribute or facilitate distribution of periodic reports of study status including, CRF completion status, missing pages, query aging, etc.
- Participate in cross functional team meetings as requested.
- Coordinate with SAS programmers to create and validate database design and edit check specifications.
- Communicate with all departments regarding project statuses/issues, provide ongoing feedback on data management workflows to increase efficiency and provide feedback to CRAs.