Clinical Trial Manager

Genmab


Dato: for 10 timer siden
By: København, Region Hovedstaden
Kontrakttype: Entreprenør
At Genmab, we are dedicated to building extra[not]ordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.

Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.

Does this inspire you and feel like a fit? Then we would love to have you join us!

The Role

At Genmab, we’re looking for a Clinical Trial Manager to join our dynamic global Trial Strategy and Delivery team of over 75 passionate professionals in Denmark, the US, the Netherlands, and Japan. In this role, you’ll manage critical trial activities such as vendor oversight, site selection, and operational setup (e.g., DM, IRT, and eRT) while being part of a team that thrives on collaboration, innovation, and a “knock-your-socks-off” spirit. From Day One, our comprehensive onboarding program will ensure you’re ready to succeed with the support of mentors, colleagues, and stakeholders.

Responsibilities

  • Developing operational plans, charters, and trial manuals.
  • Reviewing trial protocols, amendments, and other critical trial documents.
  • Leading the creation of the Trial Oversight Plan and Global Master ICF, including amendments.
  • Coordinating site selection with the Start-Up team, reviewing regulatory documents, and approving site activations.
  • Overseeing vendor management, including vendor deliverables, and ensuring alignment on trial activities.
  • Supporting trial execution by managing protocol deviations, tracking KPIs/KQIs, resolving site issues, and participating in Risk-Based Quality Management (RBQM) activities.
  • Collaborating with cross-functional teams to address escalations and ensure timely issue resolution.
  • Participating in inspection readiness, audits, and site monitoring oversight activities as needed.

Requirements

  • Experience: A Bachelor’s or master’s in medical, biological, or pharmaceutical sciences (or equivalent). With 3-5+ years of experience in clinical trial management from a pharmaceutical company and/or CRO, ideally within oncology or first-in-human trials.
  • Expertise: Strong knowledge of trial execution, GCP, and clinical drug development, with experience operating in a global setting.
  • Skills: Exceptional communication skills (written and verbal), risk management abilities, and stakeholder management.
  • Soft Skills: A proactive problem solver who identifies risks and develops effective mitigations. A collaborative leader with a quality mindset, adaptability in fast-paced environments, and the ability to inspire trust.

About You

  • You are genuinely passionate about our purpose
  • You bring precision and excellence to all that you do
  • You believe in our rooted-in-science approach to problem-solving
  • You are a generous collaborator who can work in teams with a broad spectrum of backgrounds
  • You take pride in enabling the best work of others on the team
  • You can 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 maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you’re in one of our 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 to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. 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 international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.

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.
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