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Clinical Document Lead
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Full-time
- The Clinical Document Lead (CDL) is responsible for the high-level QC of the eTMF and for all work completed by the Clinical Document Specialist (CDS) Team. As a senior employee, the CDL is involved in helping to mentor and train new employees with direction from the CDTM. The CDL is also r sponsible for reporting on deadlines to the Project Manager and Client when needed.
- Responsible for review of study documentation for Trial Master File (TMF) quality for sponsor and/or CRO
- Proactive in researching eTMF or available resources to find answers to the queries at indexing and review
- Conduct retraining for team members as required on an ongoing basis keeping PMs and Senior TMF Quality
- Assist Senior TMF Quality Specialist in performing internal audits when needed
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