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Clinical Trial Manager

Company: Genmab
Location: Princeton
Posted on: June 5, 2024

Job Description:

Job DescriptionAt 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.OverviewThe Clinical Trial Manager (CTM) is accountable for delivery of selected and/or regional deliverables within a trial (e.g., manage and oversee vendor deliverables, collaborate with functions to set up activities [e.g., Calyx, IRT, eRT], support site activation and recruitment, support data review/cleaning activities, support PI/ICF development). Scope of responsibilities depending on number of patients/sites/size of trial.Roles & Responsibilities Trial Planning and Oversight

  • Develop operational plans, manuals and charters for the trial​
  • Review protocol and protocol amendments​
  • Create and coordinate the writing of Investigational Medicinal Product (IMP) Plan (until process moved to GDS responsibility expected Q4/ end October after this date responsible for co-authoring only )​
  • Coordinate the development of the Trial Oversight Plan​
  • Review the Investigator's Brochure (IB) from DevOps perspective​
  • Review the Clinical Trial Application (CTA) submission package​
  • Review Regulatory Green Light (RGL) packages in accordance with QDOC-08903​
  • Review the Development Safety Update Report (DSUR)​
  • Develop Global Master ICF ​
  • Follow up on Trial Oversight identified findings during Oversight until closureSite Selection and Management
    • Drives site selection in collaborate with Start-up ​
    • Review/approve SSV summary ​
    • Coordinate the review of the CRO country-specific informed consent forms (ICFs) with internal stakeholder​
    • Coordinate translation/back translation process of ICFs Vendor Management and Oversight
      • Oversee vendor management across vendors (does not include budget/change orders)​
      • Approve key CRO staff e.g., Clinical leads, or Trial specific CRA (not including CRAs part of the partnership dedicated model which is managed via Oversight Manager)Trial Execution and Monitoring
        • Conduct initial Protocol Deviation (PD) assessments and track trends​
        • Ensure the ongoing completeness of the electronic Trial Master File (eTMF) ​
        • Keep the Trial Management Dashboard (TMD) and portfolio app in GenSense up to date​
        • Drive the ODB review meeting​
        • Participate in RBQM activities (as implemented going forward)​
        • Assist in maintenance of CTT issue log in collaboration with GCTM​
        • Collaborate or manage study escalations both internal & external ​
        • Support GCTM to Assess KPI/KQI at the trial level​
        • Support QA in site audit activities and potentially vendor audits (supporting with trial information and collection and providing of relevant trial documents)​
        • Conduct booster visits ​
        • Participate in inspection readiness activities as assigned​
        • Oversee and collaborate with CTT members/vendors/assigned functional representatives on tracking and reconciliation of trial related items such as scans, blood samples etc.Competencies
          • Understanding of trial execution (knowledge of the processes, procedures, and principles involved in conduction clinical trials)​
          • Experience in clinical drug development & GCP​
          • Role model the Genmab ONE team spirit​
          • Excellent written and oral English communication skills ​
          • Ability to proactively identify risks, develop mitigations, & resolve issues​
          • Stakeholder management both internal and external​
          • Ability to escalate issues as appropriate to internal or external stakeholders​
          • Experience with operating in a Global settingsFor US based candidates, the proposed salary band for this position is as follows:$95,625.00---$159,375.00The 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 soLocationsGenmab 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.About GenmabGenmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO™) antibody medicines.Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. Our commitment to diversity, equity, and inclusionWe are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website. Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website https://www.genmab.com/privacy.Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.

Keywords: Genmab, Trenton , Clinical Trial Manager, Accounting, Auditing , Princeton, New Jersey

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