Senior Clinical Trial Associate
2 weeks ago
We are seeking a highly skilled Senior Clinical Trial Associate to join our team at Genmab. As a key member of our Clinical Trials team, 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 ResponsibilitieseTMF 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.
- 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.
- 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.
- 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.
- 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.
Genmab is a biotechnology company that leverages the effectiveness of an agile working environment for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories.
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