Job Description
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.
Job Tags
Remote job, Contract work