About the job
- Serve as the primary liaison for project teams and company departments on all matters related to clinical data management.
- Act as the main contact for clients and vendors concerning all aspects of data management in clinical projects and reporting.
- Oversee and supervise all data management activities for assigned studies.
- Coordinate data management functions within clinical projects, including EDC development, data collection, data cleaning, reconciliation, database locking, final integrated database development, and delivery of final data management outputs.
- Contribute insights into project scope, budgeting, timelines, and deliverables.
- Manage clinical data management tasks such as study documentation creation, user acceptance testing, user access management, data review, eCRF/external data reconciliation, SAE reconciliation, query management, study database lock activities, archival of CRFs, quality control coordination, project status reporting, and generation of data listings/patient profiles.
- Ensure quality control of the electronic Trial Master File (eTMF).
- Maintain and quality control data management working files.
- Participate in internal and external audits/inspections of data management practices.
- Assist in the resolution of audit findings related to data management.
- Provide training to Lead Data Managers, Data Managers, and Assistant Data Managers.
- Conduct project-specific training for clinical teams on CRF completion and present at investigator meetings.
- Contribute to proposal development and support business development initiatives.
- Engage in process improvement efforts at the corporate and departmental levels.

