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.