Jobs and Careers
GE

Sr. Associate/Manager, Clinical Trial Disclosure & Transparency

Genmab
Copenhagen, DenmarkRemotefull_timeVerifiedPosted 8 Jul 2024

About the role

<p><span>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.</span></p><p></p><p>Genmab is committed to promoting transparency in clinical trial research. We recognize the scientific and ethical value of sharing clinical trial information in an unbiased and timely manner, benefiting patients and external stakeholders alike. Our Clinical Trial Disclosure &amp; Transparency (CTD&amp;T) team, part of Development Operations, plays a crucial role in ensuring successful clinical trial conduct and reporting.</p><p></p><p>We are now expanding our CTD&amp;T team with a Sr. Associate/Manager position. Besides interesting and developing tasks, you will get a unique opportunity to join a collaborative team of passionate and innovative colleagues.</p><p></p><p><b>Location</b>: This role can be based in Copenhagen, Denmark (DK), or Utrecht, Netherlands (NL), and offers a hybrid work arrangement.</p><p></p><p><b>Role Overview</b> </p><p>As a <span>Sr. Associate/</span>Manager in the Clinical Trial Disclosure &amp; Transparency team, you will be responsible for executing global and national clinical trial disclosure requirements across Genmab’s entire portfolio. Your key responsibilities include supporting trial teams, ensuring high-quality disclosure of clinical trial information, implementing new transparency requirements, and overseeing the relationship with our disclosure vendor(s) to ensure efficiency and compliance.</p><p></p><p><b>Key responsibilities</b></p><ul><li><p>Manage, track, and oversee public disclosure of clinical trial protocols, results, and document redaction.</p></li><li><p>Develop and maintain timelines for protocol registration and results disclosure on platforms such as ClinicalTrials.gov and EU CTIS and other applicable trial <span><span>registries/platforms.</span></span></p></li><li><p>Author or oversee the development of plain language results summaries.</p></li><li><p>Develop and update SOPs, templates, and oversee applicable system implementations. Assess technology/AI needs and manage implementation of required software.</p></li><li><p>Train internal staff and vendors on disclosure processes to ensure regulatory compliance.</p></li><li><p>Monitor the external landscape to ensure Genmab’s adherence to relevant industry guidelines.</p></li><li><p>Management of unsolicited requests via the <a href="mailto:clinicaltrials@genmab.com" rel="noopener noreferrer" target="_blank"><span><span><span>clinicaltrials@genmab.com</span></span></span></a><span> mailbox.</span></p></li></ul><p></p><p><b>Requirements</b></p><ul><li><p>Previous experience with clinical trial disclosure</p></li><li><p>Bachelor’s degree minimum</p></li><li><p>1-3+ years of pharmaceutical industry experience with a good understanding of clinical development</p></li><li><p>Excellent written and verbal communication skills.</p></li></ul><p>Moreover, you meet the following personal requirements:</p><ul><li><p>Engaged colleague with a positive and collaborative mindset.</p></li><li><p>Goal- and improvement-oriented with proven track record of deliveries against set timelines.</p></li><li><p>Strong organizational skills with ability to plan and prioritize tasks.</p></li><li><p>Proven ability to work with a high level of integrity, accuracy, and attention to details.</p></li><li><p>Committed to contributing to the overall success of Genmab.</p></li></ul><p></p><p><b>About You</b></p><ul><li>You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment</li><li>You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving</li><li>You are a generous collaborator who can work in teams with diverse backgrounds</li><li>You are determined to do and be your best and take pride in enabling the best work of others on the team</li><li>You are not afraid to grapple with the unknown and be innovative</li><li>You have experience working in a fast-growing, dynamic company (or a strong desire to)</li><li>You work hard and are not afraid to have a little fun while you do so</li></ul><p></p><p><b>Locations</b></p><p>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 thr

Apply for this role

Generate a tailored application kit with a matched cover letter, interview prep, and CV highlights — in under 60 seconds.

Apply Now →Generate Application Kit

Free account required — sign up in 30s

Company

Genmab

View company profile →