Senior Manager, Contracts Management

Position Summary

We are seeking an experienced Senior Manager, Contracts Management to join our Legal team as a full-time employee. This role will lead the drafting, negotiation, and management of clinical trial agreements and related clinical research contracts supporting our global clinical development programs, with global study sites, institutions, and vendors, including in the United States, Europe, and Australia. The role will also support the company's general and administrative functions on confidentiality agreements, commercial agreements, and vendor selection, and will administer and optimize the company's contract lifecycle management (CLM) system and workflows.

Key Responsibilities

Clinical Trial Agreements & Global Contract Negotiation

• Draft, review, negotiate, and manage clinical trial agreements (CTAs) and related clinical research contracts, including site and institution agreements, investigator-initiated study agreements, CRO master services agreements and work orders, and amendments, for global clinical trials in the United States, Europe, and Australia.
• Negotiate study site budgets and payment terms in partnership with Clinical Operations and Finance, ensuring fair market value and alignment with protocol requirements.
• Apply working knowledge of jurisdiction-specific clinical trial frameworks and templates, including the EU Clinical Trials Regulation (EU CTR), Medicines Australia standard form agreements, and U.S. institutional and academic medical center requirements.
• Address key clinical contracting issues, including indemnification, insurance, subject injury, intellectual property, publication rights, confidentiality, and data protection (including GDPR, HIPAA, and the Australian Privacy Act).
• Draft and negotiate ancillary clinical and R&D agreements, including confidentiality agreements, data processing agreements, laboratory and vendor services agreements, consulting and HCP agreements, and material transfer agreements.
• Develop, maintain, and standardize CTA templates, budget templates, and negotiation playbooks with pre-approved fallback positions to accelerate study start-up timelines.
• Oversee CRO-delegated site contracting, including management of CRO contract teams, escalation pathways, and adherence to approved templates and fallback positions.
• Track contracting status and cycle times against study start-up milestones, and create, run, and distribute contract metrics and status reports for Legal and business leadership.
• Coordinate contract execution, including e-signature routing to appropriate signatories in accordance with the company's signature authority policy.
• Maintain contract repositories and ensure proper filing, version control, and accessibility of executed agreements and amendments.

Contract Operations & Business Partnership

• Serve as the primary contracting partner to Clinical Operations, Clinical Development, Medical Affairs, Regulatory, Quality, Finance, and G&A functions on contracting matters, identifying legal and regulatory risk.
• Draft, review, and negotiate confidentiality agreements and routine contracts supporting G&A functions, including software/SaaS, IT, facilities, professional services, and other vendor agreements.
• Partner with business stakeholders on vendor selection, including RFP support, vendor due diligence, and evaluation of contract terms and risk.
• Lead contract intake, tracking, and lifecycle management using the company's contract lifecycle management (CLM) system, including designing, administering, and optimizing CLM workflows, intake forms, approval routing, and signature authority controls.
• Drive continuous improvement of contracting workflows, including evaluation and implementation of AI and legal technology tools.
• Partner with Compliance on Healthcare Professional (HCP) contracting, anti-bribery and anti-corruption requirements (including the FCPA and applicable local laws), and transparency reporting requirements.
• Develop and deliver training for business stakeholders on contracting processes, templates, and best practices.
• Monitor renewals, expirations, and terminations of executed agreements, and manage contract close-out at study completion.
• Manage relationships with local counsel in ex-U.S. jurisdictions.

Required Qualifications

• Bachelor's degree required; J.D., LL.B., or equivalent legal training or paralegal certification preferred.
• At least eight (8) years of contracts management experience in an in-house legal or clinical contracting function at a biotech, pharmaceutical, or CRO organization, or at a law firm with a life sciences practice.
• Deep, hands-on experience drafting and negotiating clinical trial agreements and site budgets globally, including demonstrated experience with global studies in the United States, Europe, and Australia.
• Experience negotiating with U.S. academic medical centers and research institutions.
• Strong working knowledge of clinical research regulations and standards, including ICH-GCP, the EU Clinical Trials Regulation, GDPR, HIPAA, and Australian clinical trial and privacy requirements.
• Experience with a broad range of life sciences agreements, such as CRO, vendor, consulting, HCP, data processing, and material transfer agreements.
• Experience negotiating CDAs and general commercial agreements, including software/SaaS and services agreements.
• Experience supporting vendor selection processes, including RFPs and vendor due diligence.
• Experience configuring or administering contract lifecycle management (CLM) systems, including workflows and approval processes; CLM implementation experience a plus.
• Experience using AI and legal technology tools to improve contracting workflows.
• Proven ability to serve as a trusted business partner and independently manage a high-volume contract portfolio with competing priorities and study timelines.
• Excellent negotiation, written, and verbal communication skills, with the ability to explain legal risk clearly to non-legal stakeholders.
• Strong project management skills and ability to work across time zones with internal teams, CROs, and study sites.
• High level of discretion and ability to handle confidential information.
• Analytical mindset with strong judgment and problem-solving capabilities.
• Ability to work independently and as part of a collaborative team.
• Ability to be onsite at least 3 days per week, with or without reasonable accommodation.