Sr. Manager, Site Contracts

GenmabPlainsboro Township, NJ
1d

About The Position

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 Sr. 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.

Requirements

  • 7+ 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
  • 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

Responsibilities

  • 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).
  • Act as the central point within Genmab and our sites for all matters related to CTA execution, storage and management.
  • 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.
  • 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.
  • 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.
  • 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.

Benefits

  • 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
© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service