Kardigan

Senior Contracts Manager, Clinical Agreements

Princeton, New Jersey, United States. Posted a month ago

The role

This person will lead the negotiation and management of Clinical Trial Agreements and other clinical-related agreements. They will also handle general contracting needs across the business.

What you will do

  • Independently draft, review, and negotiate Clinical Trial Agreements, Local Sponsor Agreements, and CRO agreements.
  • Draft and negotiate clinical-adjacent agreements including Data Sharing, Data Processing Agreements, GDPR clauses, Informed Consent Forms, and more.
  • Serve as the primary contracts point of contact for Clinical Operations.
  • Track key clinical contract obligations, milestones, renewals, and deadlines.
  • Build and maintain relationships with clinical sites, CROs, CMOs, and investigators.
  • Stay current on clinical trial regulatory and industry requirements.
  • Draft, review, and negotiate vendor and supplier agreements, MSAs, SOWs/WOs, consulting agreements, and NDAs.
  • Translate business needs into clear, legally sound contract language.
  • Identify, assess, and escalate legal and business risks.
  • Ensure contractual terms comply with applicable laws, company policies, and industry regulations.

Required qualifications

  • At least 7–10 years of relevant contracts experience.
  • Substantial, hands-on experience drafting and negotiating Clinical Trial Agreements and related clinical agreements within the pharmaceutical, biotech, or life sciences industry.
  • Proven track record negotiating CRO and vendor agreements, data privacy agreements (GDPR/Standard Contractual Clauses), and reviewing Informed Consent Forms.
  • Working knowledge of the clinical trial regulatory framework (e.g., GCP, ICH) as it relates to contracting.
  • Comfortable also handling general commercial contracts (vendor, consulting, NDA, MSA/SOW) outside the clinical space.
  • Experience with contract lifecycle management systems, e-signature platforms (e.g., DocuSign), and collaboration tools.
  • Strong organizational and planning skills.
  • Excellent issue-spotting, problem-solving, and communication skills.
  • Proficient in Microsoft Office Suite.
  • Commitment to integrity, ethical conduct, and handling confidential information with discretion.
  • Meticulous attention to detail.

Nice to have

  • Bachelor’s degree
  • paralegal certification
  • prior experience with Agiloft

About the company

Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. It has a cutting-edge discovery and translational research platform and a pipeline of late-stage candidates.

Senior Contracts Manager, Clinical Agreements at Kardigan | JobZoey