Senior Clinical Trial Associate

4 weeks ago

Copenhagen, Copenhagen, Denmark Genmab Full time

The Role

The Senior Clinical Trial Associate (CTA) is responsible for overseeing the filing of documents (eTMF) to ensure inspection readiness at the trial level and supporting 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 – what you must have

  • 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.

Where you will work

This role can be located in Princeton, NJ and is hybrid.

For US based candidates, the proposed salary band for this position is as follows:

$76,000---$100,000

The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as bonuses.

About You

  • You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment.
  • You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving.
  • You are a generous collaborator who can work in teams with diverse backgrounds.
  • You are determined to do and be your best and take pride in enabling the best work of others on the team.
  • You are not afraid to grapple with the unknown and be innovative.
  • You have experience working in a fast-growing, dynamic company (or a strong desire to).
  • You work hard and are not afraid to have a little fun while you do so.

Locations

Genmab leverages the effectiveness of an agile working environment, when possible, 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. Whether you're in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.

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