Clinical Contracts Manager, Cambridge, MA

Your impact 

The Clinical Contracts Manager acts as the primary point of contact for all vendor outsourcing and business contracting initiatives within their assigned therapeutic and functional areas. Operating at an organizational level, this role drives vendor selection, supports negotiation of Master Service Agreements (MSAs) and Clinical Trial Agreements (CTAs), and manages vendor related study budgets and contract lifecycle activities. The Clinical Contracts Manager collaborates closely with Clinical Operations, Data Management, Clinical Sciences, Clinical Systems, Biosample Operations, Finance, Legal, and other cross-functional stakeholders to ensure predictable trial execution, financial alignment, and compliance with GCP and FDA regulatory standards.

What you will do 

Vendor Management & Contracting

• Provide primary outsourcing and vendor management support for clinical development functional areas across the portfolio.
• Independently lead RFI and RFP processes, analyze supplier services, proposals, and budgets, conduct bid defense meetings, and recommend vendor selection for executive decision-making.
• Negotiate and execute complex vendor agreements and Master Service Agreements (MSAs) with preferential terms and pricing.
• Define and implement vendor assessment criteria, benchmark metrics, and process improvement initiatives to optimize clinical outsourcing.

Clinical Trial Execution & Site Support

• Drive negotiations for Clinical Trial Agreements (CTAs) and investigator budgets directly with clinical sites.
• Partner closely with Clinical Trial Managers, program teams, and CROs to ensure vendors deliver against study timelines, quality standards, and budget expectations.
• Assess and integrate potential AI tools to facilitate and enable contract negotiations and management.
• Ensure full consistency between contractual agreements and operational trial implementation.
• Monitor study progress, vendor deliverables, and resource allocation throughout the study lifecycle, supporting teams in final financial reconciliation at study closeout.

Risk Management, Compliance & Governance 

• Actively monitor study progress for scope changes, driving negotiations for change orders and associated costs to minimize sponsor risk.
• Identify contractual risks, mitigate scope creep, and ensure strict adherence to Fair Market Value (FMV) standards, legal requirements, and healthcare compliance.
• Proactively address contractual challenges, develop risk mitigation plans, and facilitate escalation management for leadership review when needed.
• Participate in vendor oversight and governance meetings, supporting study teams in resolving vendor performance issues.
• Seek out, assess and potentially assist in onboarding potential AI solutions within this space that would prove helpful to the organization 

Skills and qualifications 

Essential:

• Bachelor’s degree (BA/BS); degree in Healthcare, Science or Finance preferred.
• Minimum 5+ years of experience in clinical outsourcing, contracting, procurement, or finance within a pharmaceutical, biopharma, CRO, or clinical research setting. 
• In-depth knowledge of clinical trial execution, CRO outsourcing models, and regulatory guidelines (GCP/FDA). 
• Oncology and/or Rare Disease experience required. 
• Ability to confidently and independently complete and/or drive all key responsibilities listed above. 
• Strong contract negotiation, budget management, and project management skills with a proven track record across multi-project timelines.
• Exceptional written and oral communication skills, with the ability to convey engagement objectives and maintain effective dialogue with internal and external partners.
• Demonstrates an AI-curious mindset, with an interest in exploring and leveraging emerging AI technologies to streamline contract lifecycle management and enhance operational efficiency.
• Strategic and analytical thinker with excellent problem-solving capabilities and adaptability in fast-paced, matrixed environments.
• Proven ability to build strong cross-functional relationships, mentor team members, and drive efficient business solutions across functional and regional boundaries.