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.
This role is hybrid and offers flexibility to work away from the office for 20%-40% of a typical schedule. Employees may use this work schedule in increments of single days or multiple consecutive days, provided it does not exceed 40% within a 60-day period, and is approved by the hiring manager.
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- Bachelor's degree and 7+ years of direct industry experience required
- Experience in relevant operations and/or R&D functions, the biotechnology/ pharmaceutical, CRO, or healthcare industry
- 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
For US based candidates, the proposed salary band for this position is as follows:
$134,320.00---$201,480.00
The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.
When you join Genmab, you're joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for:
- 401(k) Plan: 100% match on the first 6% of contributions
- Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
- Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
- Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
- Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
- Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses
Further details on eligibility for compensation and benefits based on role will be provided during the recruitment process