About the Role
**Responsibilities include, but are not limited to**:
- Trial and site administration:
- Track (e.g. essential documents) and report (e.g. Safety Reports)
- Ensure collation and distribution of study tools and documents
- Update clinical trial databases and trackers
- Document management:
- Prepare documents and correspondence
- Collate, distribute/ship, and archive clinical documents, e.g. eletronic Trial Master File (eTMF)
- Assist with eletronic Trial Master File (eTMF) reconciliation
- Execute eletronic Trial Master File (eTMF) Quality Control Plan
- Update manuals/documents (e.g., patient diaries, instructions)
- Document proper destruction of clinical supplies.
- Prepare Investigator trial file binders
- Obtain translations of documents
- Regulatory & Site Start-Up responsibilities:
- In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
- Obtain, trac...
- Trial and site administration:
- Track (e.g. essential documents) and report (e.g. Safety Reports)
- Ensure collation and distribution of study tools and documents
- Update clinical trial databases and trackers
- Document management:
- Prepare documents and correspondence
- Collate, distribute/ship, and archive clinical documents, e.g. eletronic Trial Master File (eTMF)
- Assist with eletronic Trial Master File (eTMF) reconciliation
- Execute eletronic Trial Master File (eTMF) Quality Control Plan
- Update manuals/documents (e.g., patient diaries, instructions)
- Document proper destruction of clinical supplies.
- Prepare Investigator trial file binders
- Obtain translations of documents
- Regulatory & Site Start-Up responsibilities:
- In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
- Obtain, trac...
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