Note: The job is a remote job and is open to candidates in USA. Integrated Resources, Inc. (IRI) is the company offering this clinical contracting role. The Clinical Contracts Analyst III supports end-to-end contracting for complex clinical vendor categories, including specification management, budget development, vendor negotiation, Statements of Work, amendments, and compliance. The role partners with Clinical Operations, Category Management, Finance, Legal, and preferred vendors to meet study timelines and governance requirements.
Responsibilities
- Job Overview 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 Product 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
- 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 Product, assumptions, and master pricing frameworks
- Conduct pricing comparisons across approved preferred vendors, evaluating cost drivers, service models, and operational implications
- Ensure Product integrity by eliminating duplication, clarifying responsibilities, and aligning deliverables to the governing MSA structure
- Partner with Clinical Operations to proactively identify Product changes and incorporate them into budget and contractual updates
- Negotiate Product, 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, Product, 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, Product, or performance trends impacting vendor strategy
Skills
- Demonstrated experience managing complex clinical vendor categories (e.g., CROs, central labs, clinical technology services)
- Strong expertise in specification development, Product validation, and vendor budget modeling
- Proven ability to negotiate pricing and Product 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 Product, 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
Company Overview
Company H1B Sponsorship