Sr. Associate/Manager, Clinical Trial Disclosure
2 months ago
Sr. Associate/Manager, Clinical Trial Disclosure & Transparency
Sr. Associate/Manager, Clinical Trial Disclosure & TransparencyLocation : This role can be based in Copenhagen, Denmark (DK), or Utrecht, Netherlands (NL), and offers a hybrid work arrangement.
Role Overview
As a Sr. Associate/Manager in the Clinical Trial Disclosure & 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.
Key responsibilities
- Manage, track, and oversee public disclosure of clinical trial protocols, results, and document redaction.
- Develop and maintain timelines for protocol registration and results disclosure on platforms such as ClinicalTrials.gov and EU CTIS and other applicable trial registries/platforms.
- Author or oversee the development of plain language results summaries.
- Develop and update SOPs, templates, and oversee applicable system implementations. Assess technology/AI needs and manage implementation of required software.
- Train internal staff and vendors on disclosure processes to ensure regulatory compliance.
- Monitor the external landscape to ensure Genmab’s adherence to relevant industry guidelines.
- Management of unsolicited requests via the mailbox.
Requirements
- Previous experience with clinical trial disclosure.
- Bachelor’s degree minimum.
- 1-3+ years of pharmaceutical industry experience with a good understanding of clinical development.
- Excellent written and verbal communication skills.
Moreover, you meet the following personal requirements:
- Engaged colleague with a positive and collaborative mindset.
- Goal- and improvement-oriented with proven track record of deliveries against set timelines.
- Strong organizational skills with ability to plan and prioritize tasks.
- Proven ability to work with a high level of integrity, accuracy, and attention to details.
- Committed to contributing to the overall success of Genmab.
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.
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.
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