Senior Clinical Trial Associate

3 weeks ago

Copenhagen, Copenhagen, Denmark Genmab Full time
Job Title: Senior Clinical Trial Associate

Genmab is seeking a highly skilled Senior Clinical Trial Associate to join our team. As a key member of our Clinical Trials department, you will be responsible for overseeing the filing of documents to ensure inspection readiness at the trial level and supporting our GCTM/CTM with key administrative 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.
    Requirements:
    • You have a background as Clinical Trial Associate from a similar position or have an education as registered nurse or similar.
    • Preferably you have worked at least 3 years in an administrative position within the pharmaceutical industry and are experienced in the planning and execution of clinical trials.
    • Experience maintaining and tracking critical documentation.
    • You are proficient with both written and spoken English.
    • You are highly skilled within MS Office and have flair for using IT systems.
    What We Offer:
    • A dynamic and collaborative work environment.
    • Opportunities for professional growth and development.
    • A competitive salary and benefits package.
    • The chance to work on innovative cancer treatments and make a meaningful impact on patients' lives.
    Location:

Genmab is headquartered in Princeton, NJ, and this role can be located in our Princeton office. We offer a hybrid work arrangement, allowing you to balance your work and personal life.

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