Senior Clinical Trial Associate

2 weeks ago


Copenhagen, Copenhagen, Denmark Genmab Full time

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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