Clinical Outsourcing Contract Manager - REMOTE

REMOTE / EST business hours Pay: $76.15-$79.61/hour. W2 Clinical Program Sourcing & Contract Management (CPSCM) Manager is responsible for leading end-to-end study-level contracting execution for complex clinical vendor categories supporting global clinical trials (Phase I–IV). Reporting to the Sr. Manager, CPSCM, this role serves as the contracting lead for high-value and high-impact service areas such as CRO services, central laboratories, clinical technology providers, and other large functional service categories. This role works exclusively with established preferred vendors operating under existing Master Service Agreements (MSAs) owned by Category Management. This role is accountable for managing the specification intake process with Clinical Trial Leads (CTLs) and Study Teams, developing and negotiating vendor budgets, ensuring scope accuracy, preventing duplication of services, and executing Statements of Work (SOWs), amendments, and closeout documentation in alignment with study timelines and Vendor Sourcing Timelines (VSTs). The Manager serves as a key procurement partner to Clinical Operations, Category Management, Finance, and Legal to ensure study timelines, commercial frameworks, and governance requirements are met while delivering compliant, commercially sound, and predictable contracting outcomes. Specification Management & Budget Development (Complex Categories) (25%) 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. Quantitative Sciences Development Operations (QSDO) including, but not limited to: Clinical Trials Delivery Unit (CTDU) Country Site & Operations (CSO) Clinical Trial Accelerator Unit (CTAU) Strategic Resourcing & Performance Optimization (SRPO) Clinical Operations, China Clinical Development Unit, Japan Procurement Clinical Services, Category Management Procurement Clinical Program Sourcing & Contract Management (CPSCM) Contract Negotiation, Execution & Cycle Time Accountability (70%) 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. Commercial Compliance & Governance Execution (5%) 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. Education & Experience Bachelor's degree required (Business, Life Sciences, or related field) Advanced degree and/or legal/contracting background is a plus Procurement certifications (e.g., CPSM/C.P.M.) desirable 5-7 years of procurement, sourcing, or contract management experience within biotech/pharma or similarly regulated industries. Qualifications Demonstrated experience managing complex clinical vendor categories (e.g., CROs, central labs, clinical technology services) is required. 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. #J-18808-Ljbffr The Fountain Group