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LHH
Contracts Manager/Attorney (Part-Time Contract)LHH • Carlsbad, CA, United States
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Contracts Manager/Attorney (Part-Time Contract)

Contracts Manager/Attorney (Part-Time Contract)

LHH • Carlsbad, CA, United States
5 days ago
Job type
  • Part-time
Job description

Clinical Contracts Manager

LHH is partnering with a biotechnology company to identify a highly experienced Clinical Contracts Manager for a contract engagement. This role is heavily focused on Clinical Trial Agreements (CTAs) with clinical sites, including hospitals, academic medical centers, and research institutions. This position requires deep expertise in negotiating and managing site-facing legal and operational terms that directly impact clinical trial execution. The ideal candidate will bring extensive hands-on experience supporting Clinical Operations teams by negotiating complex CTAs, resolving contract issues that delay or block study start-up, and navigating data privacy and compliance considerations across domestic and international trials. This role requires a senior-level professional who can independently lead negotiations, proactively identify risk, and partner closely with cross-functional stakeholders in a fast-paced biotech environment.

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

Qualifications

  • 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
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Contracts Manager/Attorney (Part-Time Contract) • Carlsbad, CA, United States

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