Manager, Site Contracts at Genmab US, Inc.

Copenhagen Municipality, Capital Region of Denmark, Denmark -

Full Time

Start Date

Immediate

Expiry Date

29 May, 26

Salary

0.0

Posted On

28 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Contract Negotiation, Clinical Trial Agreements, FMV Negotiation, Site Financial Agreements, GCP, ICH, FDA Guidelines, EMA Guidelines, Document Management, Stakeholder Communication, Risk Mitigation, Microsoft Office, SaaS Platforms, Regulatory Compliance, Trial Start-up, Record Management

Industry

Biotechnology Research

Description

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! Position Summary The Contract Manager leads the end-to-end management of Clinical Trial Agreements (CTAs), Fair Market Value (FMV) negotiations and payment processes. As the primary contact for clinical trial sites, the role ensures our site contracts meet legal and regulatory requirements, real-time metrics and proper document management. The position requires strong communication and follow-up skills that directly contribute to faster study start-up timelines and smooth trial execution. Key Accountabilities (including but not limited to) End-to-End Site Contract Management Lead and oversee the full lifecycle of Clinical Trial Agreements (CTAs), including drafting, reviewing, negotiating, FMV, executing, and maintaining contracts. Implement, when possible, Master Clinical Trial (MCTAs) and support CTA amendments (as applicable). Primary Contact for Contract Execution Act as the central point within Genmab and our sites for all matters related to CTA execution, storage and management. Legal and Regulatory Compliance Ensure all CTAs and final site budgets remain in alignment with current legal, regulatory, and compliance requirements. Collaborate with Legal and Compliance teams to integrate evolving requirements into contracts. Documentation and Record Management Maintain complete, accurate, and inspection-ready documentation of all site contracts, correspondence, and approvals in accordance with internal- and regulatory requirements, as well as audit/inspection expectations. Ensure timely updates and version control across documentation systems. Stakeholder Communication & Reporting Partner with internal stakeholders to ensure transparency. Provide clear and timely updates on site contract status to the clinical trial team. Proactively contributes to trial-related meetings, ensuring alignment on contract progress, risks, and timelines. Inspection Readiness & Trial Support Support the core trial team in ensuring all site-level documentation and contracts are audit- and inspection-ready. Contribute to risk mitigation and resolution of issues impacting trial timelines or site engagement. Qualifications/Experience (preferred professional experience level) 5 + years of experience in relevant operations and/or R&D functions, the biotechnology/ pharmaceutical, CRO, or healthcare industry Bachelor's Degree Strong expertise in Contract negotiation and site financial agreements Substantial Experience in reviewing and negotiating relevant agreements Familiarity with GCP, ICH, and relevant FDA/EMA guidelines from a financial perspective Demonstrated ability to collaborate across functional teams and communicate effectively with clinical and financial stakeholders Excellent verbal/written communication and negotiating skills · Demonstrate advanced skills in Microsoft Office applications (Excel, Word, PowerPoint, Outlook), Saas based platform tools and other industry standard programs Attributes of a successful candidate · Self-starter; motivated by working in a fast-paced, ambiguous environment · Detail oriented, timeline driven and ability to work in a structured environment as an individual and team contributor 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).

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Responsibilities

The Contract Manager leads the end-to-end management of Clinical Trial Agreements (CTAs), including FMV negotiations and payment processes, acting as the primary contact for clinical trial sites. This role ensures contracts meet legal and regulatory requirements, aiming to accelerate study start-up timelines and ensure smooth trial execution.