Clinical Program Sourcing & Contract Management Manager

Job Responsibilities:

• Lead the end-to-end specification collection process with CTLs and Study Management Teams for complex vendor categories.
• Review, validate, and refine study specifications to ensure clarity, completeness, and alignment to protocol and operational requirements.
• Develop detailed vendor budgets in collaboration with preferred vendors, ensuring alignment with scope, assumptions, and master pricing frameworks.
• Conduct pricing comparisons across approved preferred vendors, evaluating cost drivers, service models, and operational implications.
• Ensure scope integrity by eliminating duplication, clarifying responsibilities, and aligning deliverables to the governing MSA structure.
• Partner with Clinical Operations to proactively identify scope changes and incorporate them into budget and contractual updates.
• Negotiate scope, assumptions, pricing adjustments, and contractual language within the boundaries of established MSAs.
• Draft, review, and finalize Statements of Work (SOWs), amendments, change orders, and closeout agreements.
• Drive vendors to meet agreed Vendor Sourcing Timelines (VSTs) established by Program Demand Management.
• Ensure contracts meet ICH GCP standards, internal procurement policies, and regulatory compliance requirements.
• Support audit and inspection readiness by maintaining clear documentation trails and defensible commercial rationale.
• Partner with Category Management to flag recurring pricing, scope, or performance trends impacting vendor strategy.
• Ensure all SOWs and amendments adhere to approved Master Service Agreements (MSAs), rate cards, and pricing governance frameworks.
• Apply Fair Market Value (FMV) methodologies and financial controls to validate vendor proposals.
• Maintain accurate documentation within required contracting systems and repositories.
• Support audit and inspection readiness by maintaining clear documentation trails and defensible commercial rationale.
• Partner with Category Management to flag recurring pricing, scope, or performance trends impacting vendor strategy.

Skills:

• Clinical vendor management
• CRO services
• Central laboratories
• Clinical technology providers
• Study-level contracting
• Vendor budget development
• Statement of Work (SOW)
• Master Service Agreements (MSAs)
• Contract negotiation
• Vendor Sourcing Timelines (VSTs)
• ICH GCP
• Fair Market Value (FMV)
• Clinical Operations collaboration
• Procurement and governance
• Regulatory compliance
• Commercial acumen
• Stakeholder management
• Cross-functional collaboration
• Documentation management
• Audit and inspection readiness

Education/Experience:

• Demonstrated experience managing complex clinical vendor categories (e.g., CROs, central labs, clinical technology services).
• Strong expertise in specification development, scope validation, and vendor budget modeling.
• Proven ability to negotiate pricing and scope within established MSA frameworks.
• Deep understanding of end-to-end clinical trial contracting workflows and study start-up timelines.
• Strong commercial acumen and ability to identify pricing discrepancies, duplication of scope, and contract risk.
• Experience driving vendors to meet contracting cycle times and operational milestones.
• Highly organized with ability to manage multiple complex contracts concurrently.
• Strong stakeholder management and cross-functional collaboration skills.
• Detail-oriented with disciplined compliance mindset.
• Excellent written and verbal communication skills.