Senior Clinical Trial Associate
2 weeks ago
Job Summary
The Senior Clinical Trial Associate plays a pivotal role in the success of clinical trials at Genmab.
Key Responsibilities
- eTMF Management:
- Setup, maintain, and close Sponsor eTMF (trial, country, sites, EDL, upload of documents).
- Oversight of eTMF (TMF-Browser, Monthly Review, eTMF Spot Check, review of classification as needed).
- Audit/Inspection readiness preparation.
- Meeting and Communication Management:
- Coordinate logistics for Clinical Trial Team meetings (emails, filing in eTMF, invites, recording).
- Write CTT meeting minutes.
- Coordinate logistics for Oversight Dashboard Review meetings (run reports, invites, emails, filing in eTMF, including workflow).
- Provide Clinical Trial Governance site and status updates.
Requirements
- Background as Clinical Trial Associate from a similar position or education as registered nurse or similar.
- Preferably 3 years of experience in an administrative position within the pharmaceutical industry, experienced in planning and execution of clinical trials.
- Experience maintaining and tracking critical documentation.
- Proficient with written and spoken English.
- Highly skilled in MS Office and IT systems.
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