Clinical Trial Operations Manager

3 days ago

Copenhagen, Copenhagen, Denmark Genmab Full time
About the Role

We are seeking a seasoned Senior Clinical Trial Associate to join our team at Genmab. As a key member of our Clinical Operations group, you will be responsible for overseeing the filing of documents to ensure inspection readiness at trial level and supporting GCTM/CTM with key activities.

Key Responsibilities:
  • eTMF Management:
    • Setup, maintain and close Sponsor eTMF (trial, country, sites, EDL, upload of document).
    • Oversight of eTMF (TMF-Browser, Monthly Review (Docs In Progress, EDL), eTMF Spot Check, review of classification as needed).
    • Audit/Inspection readiness preparation.
  • Meeting and Communication Management:
    • Coordinate logistics for Clinical Trial Team (CTT) meetings (emails in connection with the meeting, filing in eTMF, invites, recording).
    • Write CTT meeting minutes (guidance on how to take minutes during the CTT meeting is coming).
    • Coordinate logistics for Oversight Dashboard (ODB) Review meeting (run reports, invites, emails in connection with the meeting, filing in eTMF including workflow).
    • Provide Clinical Trial Governance (CT.Gov) site and status updates.
  • Plans and Resource Management:
    • Maintain CTT staff list in GenTrack/GenSense.
    • Maintain Vendor list in GenTrack/GenSense.
    • Setup and maintain CTT Charter.
    • Support CTM in reviewing TMD and Portfolio App in GenSense.
    • Provide input to Trial Oversight Plan.
    • Provide input to TMF Plan.
  • Clinical Study Report (CSR) Management:
    • Support filing appendices of Clinical Study Report (CSR).
    • Responsible for setting-up and maintaining the sponsor file, review, QC, and file trial-related documents in the eTMF system.
    • Support inspection preparations.
    • Support handling of site contracts, ongoing updates of the trial dashboard, trial budget maintenance and development.
    • Arrange internal and external meetings, prepare agendas, write minutes, support QC and development of graphical presentations, etc.

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