Clinical Trial Operations Coordinator

4 days ago


Copenhagen, Copenhagen, Denmark Genmab Full time
About the Role

This Senior Clinical Trial Associate position is an exciting opportunity to join our team at Genmab, a dynamic and innovative company dedicated to transforming the lives of patients through cutting-edge cancer treatment.

The ideal candidate will possess a strong background in clinical trials, with experience in administrative positions within the pharmaceutical industry. A degree as a registered nurse or similar is highly desirable, along with proficiency in MS Office and IT systems.

Key Responsibilities

The Senior Clinical Trial Associate will be responsible for overseeing the filing of documents (eTMF) to ensure inspection readiness at trial level. This involves setup, maintenance, and closure of sponsor eTMF, as well as oversight of eTMF management, including TMF-Browser, Monthly Review, eTMF Spot Check, and review of classification as needed.

An additional key responsibility is Meeting and Communication Management, which includes coordinating logistics for Clinical Trial Team meetings, writing meeting minutes, and providing site and status updates. Plans and Resource Management also falls under this role, involving maintaining CTT staff lists, vendor lists, and CTT Charter setup and maintenance.

Lastly, the Senior Clinical Trial Associate will be involved in Clinical Study Report (CSR) Management, supporting the filing of appendices, setting up and maintaining sponsor files, reviewing and QC-ing trial-related documents, and supporting inspection preparations.

Requirements

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