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    Senior Clinical Trial Associate - Princeton, United States - GENMAB A/S

    GENMAB A/S
    GENMAB A/S Princeton, United States

    3 weeks ago

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    Description

    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.

    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


    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.

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