Senior Clinical Trial Associate

2 weeks ago

Copenhagen, Denmark Genmab Full time

At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

The Clinical Trial Associate (CTA) is responsible for overseeing filing of documents (eTMF) to ensure inspection readiness at trial level & supporting GCTM/CTM with key (administrative) activities.

Roles & 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 logistic for CTT meetings (emails in connection with the mtg, 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 mtg, filing in eTMF incl 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)

Competencies

  • Planning and organization, multitasking
  • Clinical development experience
  • Process oriented
  • Communication skills – oral and written language skills
  • Problem-solving and critical thinking
  • Teamwork, vendor/stakeholder collaboration/management
  • Adaptability to change of processes
  • Cultural awareness
  • Training and mentoring, continuous learning
  • Project and data/documentation management,
  • Maintain audit readiness, quality oriented

Level differentiation

Senior CTA

  • Assigned to complex trials preferable pivotal or phase III trials, trials within new indications etc.
  • SME for processes related to CTA role 

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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