Genmab

Genmab

Contract Manager

DanmarkPosted 10 days ago
Full TimeSeniorDK

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Job Description

We are extra[not]ordinary *(ex· tra· not· or· di· nary |\ ik-ˈstr-not-ȯr-də-ˌner-ē) Adjective: A unique word for Genmab meaning to go way beyond what is usual; to be remarkable; proudly unique and aut

Key Highlights

  • 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.
  • 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

Required Qualifications

  • 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

Skills & Technologies

GoGCP

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Job Details

Employment Type

Full Time

Experience Level

Senior

Location

Danmark

Posted

10 days ago

Country

DK