About the job
As the Lead Data Manager for Clinical Trials, you will play a pivotal role in overseeing comprehensive data management activities for large, complex studies, while also managing smaller projects with minimal supervision.
Communication
- Act as the primary communication liaison for project teams and internal departments concerning clinical data management.
- Serve as the main contact point for clients and vendors regarding all data management elements of clinical projects and reporting.
Data Management
- Oversee coordination of data management tasks within clinical projects, including EDC development, data collection, cleaning, reconciliation, Database Lock, and the creation of final integrated databases and deliverables.
- Take lead on clinical data management activities, which involve:
- Review of study documents
- Development and review of Data Management plans and project-specific guidelines
- Coordination and execution of user acceptance testing
- Creation of Data Validation Plans and Edit Check Specifications
- Supervision of data entry processes and providing feedback to data entry staff regarding data quality and issues
- Conducting data validation through both automated and manual inspections, resolving discrepancies, generating queries, and communicating with clinical trial teams on data quality
- Handling non-CRF electronic data (including receiving, archiving, and loading into study databases, resolving reconciliation issues, and liaising with vendors on data quality)
- Managing database edits for paper CRF studies
- Performing manual CRF reviews (non-medical checks)
- Executing the clinical database lock
- Supervising the processing, dispatch, and archiving of CRFs/queries
- Contribute to the design of CRFs and other data collection forms, ensuring accuracy and compliance with protocols.
- Develop CRF completion guidelines.
- Engage in medical data coding using coding dictionaries and reviewing coding listings (additional training may be required for Lead DMs with medical/biology backgrounds).
- Conduct SAE reconciliation.
- Review and approve electronic data transfer specifications.
Document Management
- Collaborate with the Document Center to maintain the TMF and eTMF.
Quality Control
- Perform database QC checks and maintain thorough documentation.
- Participate in internal and third-party audits/inspections related to Data Management.
- Assist in addressing and resolving audit findings pertaining to Data Management.
Training
- Provide training and support to team members as necessary.
