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Clinical Trials Professional
1 month ago
This role is ideal for a detail-oriented and organized individual with experience in clinical trial management. The Senior Clinical Trial Associate will be responsible for overseeing the filing of documents to ensure inspection readiness at the trial level.
The role involves supporting the GCTM/CTM with key administrative activities, including eTMF management, meeting and communication management, and plans and resource management.
eTMF management responsibilities include setting up, maintaining, and closing sponsor eTMF, as well as oversight of eTMF, including TMF-Browser, Monthly Review, eTMF Spot Check, and review of classification as needed.
The successful candidate will have a background as a Clinical Trial Associate from a similar position or an education as a registered nurse. They should have experience working at least 3 years in an administrative position within the pharmaceutical industry and be experienced in the planning and execution of clinical trials.
The ideal candidate will be proficient in both written and spoken English and highly skilled in MS Office. They should also have a flair for using IT systems.
About the Role:
- This hybrid role can be located in Princeton, NJ.
- The estimated salary for this position is $95,000 - $110,000 per year.
- Certain positions are eligible for additional forms of compensation, such as bonuses.
Responsibilities:
- Support the GCTM/CTM with key administrative activities.
- Oversee the filing of documents to ensure inspection readiness at the trial level.
- eTMF management responsibilities include setting up, maintaining, and closing sponsor eTMF.
- Oversight of eTMF, including TMF-Browser, Monthly Review, eTMF Spot Check, and review of classification as needed.
- Meeting and communication management responsibilities include coordinating logistics for Clinical Trial Team (CTT) meetings and writing CTT meeting minutes.
- Plans and resource management responsibilities include maintaining CTT staff list in GenTrack/GenSense and maintaining vendor list in GenTrack/GenSense.
- Clinical Study Report (CSR) management responsibilities include supporting filing appendices of Clinical Study Report (CSR).
About Us:
Genmab is a dynamic 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.
