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Associate Director, Global Clinical Trial Management

Associate Director, Global Clinical Trial Management

GenmabUtrecht, Netherlands
28 dagen geleden
Functieomschrijving

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 Role

The Global Clinical Trial Manager (GCTM) is accountable for the end-to-end delivery of a single or multiple clinical trials from strategy outline through to CSR by leading cross-functional trial specific Clinical Trial Teams (CTT) to deliver clinical trials including managing the trial budget. The GCTM is accountable for trial deliverables and acts as point person for coordination of the TM team. The GCTM can at all times take the responsibilities of a CTM. If no CTM resource is assigned to a trial the GCTM takes on the CTM role too.

The Role

The Global Clinical Trial Manager (GCTM) is responsible for overseeing the complete lifecycle of one or more clinical trials, from initial strategy through to Clinical Study Report (CSR) completion. This role involves leading cross-functional Clinical Trial Teams (CTT) and managing the trial budget to ensure successful delivery of clinical trials. Acting as the primary coordinator for the Trial Management (TM) team, the GCTM also assumes Clinical Trial Manager (CTM) responsibilities as needed, especially when a dedicated CTM is not assigned to a trial.

Responsibilities

  • Lead the Clinical Trial Team (CTT) and Trial Management (TM) team
  • Define and align CTT goals collaboratively with the team
  • Review and approve protocol and amendment changes
  • Review the Master Informed Consent Form (ICF)
  • Approve operational plans, manuals, and charters for the trial
  • Oversee the vendor selection process
  • Initiate and verify the accuracy and completeness of initial Work Orders (WO) and Change Orders (CO)
  • Guide the country selection process
  • Coordinate responses to IEC / IRB comments
  • Monitor major protocol deviations (PDs) and trends
  • Approve data cleaning plans
  • Collaborate with CPL as needed for CST / CDT
  • Establish and maintain clear responsibility distribution
  • Review and contribute to the CSR as needed
  • Escalate issues to CPL in a timely manner
  • Execute operational strategies related to drug supply, regulatory submissions, and recruitment

Budget and Planning

  • Assist in the initial development and management of the trial budget
  • Plan, implement, and maintain detailed, integrated trial timelines from the study outline through CSR
  • Develop initial recruitment projections and strategy
  • Approve updated recruitment projections in alignment with CPL
  • Serve as the counterpart for CRO PL / PM, approving the CV of PL / PM

    • Risk Management

  • Identify study risks with the CTT and oversee risk management activities
  • Maintain and oversee the CTT issue log and ensure timely issue resolution
  • Ensure CTT action and decision logs are up-to-date
  • Support audit preparation and responses
  • Implement Corrective and Preventive Actions (CAPAs), if applicable

    • Requirements

  • Bachelor's or Master's degree with relevant specialization; Master's degree preferred
  • Minimum requirement : 5+ years in clinical operations
  • Significant experience leading clinical projects
  • Experience managing / guiding internal (cross-functional) and external (CRO, regulatory authorities) teams
  • Some experience with operational management and budget planning
  • Proven performance in earlier role / comparable 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.

    About Genmab

    Genmab 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 inclusion

    We 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 Job Applicant Privacy Notice (genmab.com) .

    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.