About the job
- Serve as the primary liaison for project teams and various departments within the company concerning clinical data management.
- Act as the main point of contact for clients and vendors on all aspects of clinical data management and associated reporting.
- Oversee the execution of all data management activities for assigned clinical studies.
- Coordinate data management efforts within clinical projects, including EDC development, data collection, data cleaning, reconciliation, database lock procedures, the creation of final integrated databases, and the production of final data management deliverables.
- Provide insights into project scope, budget management, timelines, and deliverables.
- Manage clinical data management activities, including but not limited to: study documentation development, user acceptance testing, user access management, data review, eCRF/external data reconciliation, SAE reconciliation, query management, study database lock activities, archival of CRFs, QC coordination, project status reporting, and data listings/patient profiles generation and delivery.
- Ensure quality control of eTMF and data management working files.
- Participate in the preparation and attendance of internal and external audits/inspections related to data management.
- Engage in follow-up and resolution of audit findings pertinent to data management.
- Train Lead Data Managers, Data Managers, and Assistant Data Managers.
- Conduct project-specific training for the clinical team in CRF completion and present at Investigator Meetings.
- Contribute to proposals and assist in business development initiatives.
- Take part in corporate and departmental process improvement activities.