Note: The job is a remote job and is open to candidates in USA. LHH is partnering with a biotechnology company to identify a highly experienced Clinical Contracts Manager for a contract engagement. The role focuses on independently negotiating and managing Clinical Trial Agreements, addressing legal and compliance risks, supporting data protection agreements, and partnering with Clinical Operations and cross-functional stakeholders.
Responsibilities
- Lead the preparation, review, negotiation, and execution of Clinical Trial Agreements (CTAs) with clinical sites, with a primary focus on legal, regulatory, and operational terms rather than budgets or payment schedules
- Serve as a strategic contract partner to Clinical Operations, proactively addressing site contract issues that may impact study timelines, site activation, or compliance
- Identify and mitigate key legal and compliance risks within CTAs, including publication rights, IP, indemnification, subject injury, confidentiality, data use, and termination provisions
- Support negotiation and execution of data processing and data protection agreements for domestic and international clinical trials, including familiarity with Standard Contractual Clauses and cross‑border data transfer considerations
- Collaborate with Legal, Privacy, Clinical Operations, Regulatory, Medical Affairs, R&D, and other functional teams to ensure contracts align with company policies and applicable laws
- Act as primary point of contact between internal stakeholders and external clinical sites, institutions, CROs, and research partners
- Maintain accurate and complete contract records within the contract lifecycle management (CLM) system
- Provide guidance and education to internal teams on CTA templates, playbooks, contracting standards, and best practices
- Communicate contract status, risks, and escalation issues clearly and proactively to stakeholders
- Contribute to continuous improvement of contract templates, negotiation strategies, and contracting processes
- Support special projects and cross‑functional initiatives as needed
Skills
- • JD required
- • 8+ years of experience negotiating and managing Clinical Trial Agreements (CTAs), specifically with clinical sites
- • Experience negotiating data processing and data protection terms for international clinical trials, including Standard Contractual Clauses or similar mechanisms
- • Strong understanding of clinical trial operations and experience partnering directly with Clinical Operations teams
- • Experience supporting additional biotech functional areas such as Medical Affairs, R&D, Regulatory, and/or CMC
- • Deep knowledge of contractual risk assessment and mitigation in a biotech or pharmaceutical environment
- • Experience working with CLM systems and e-signature platforms
- • Advanced proficiency in Microsoft Office applications
- • Exceptional negotiation, communication, and cross-functional collaboration skills
- • Ability to operate independently and manage multiple complex agreements simultaneously
Benefits
- Medical
- Dental
- Vision
- Life insurance
- Short-term disability
- Additional voluntary benefits
- EAP program
- Commuter benefits
- A 401K plan
- Paid Sick Leave or any other paid leave required by Federal, State, or local law
- Holiday pay where applicable
Company Overview