Title:
Clinical Program Sourcing & Contract Management Manager
Location:
Remote (U.S., Eastern Time preferred)
Pay:$65.00-$79.00/hour
Schedule:
East Coast Office Hours
Duration:
4-Month Initial Contract
We are seeking an experienced Clinical Program Sourcing & Contract Management Manager
to lead end-to-end study-level contracting for complex clinical vendor categories supporting global Phase I–IV clinical trials.
This role is responsible for managing the contracting process for high-value clinical service providers, including CROs, central laboratories, clinical technology vendors, and other strategic functional service categories. Working within established Master Service Agreements (MSAs), the Manager will partner closely with Clinical Operations, Finance, Legal, and Procurement to develop vendor budgets, negotiate Statements of Work (SOWs), manage contract amendments, and ensure timely execution while maintaining compliance with internal governance and regulatory requirements.
Responsibilities
Specification Management & Budget Development
- Lead the end-to-end specification intake process with Clinical Trial Leads (CTLs) and Study Management Teams for complex vendor categories.
- Review, validate, and refine study specifications to ensure alignment with protocol requirements and operational objectives.
- Develop detailed vendor budgets in collaboration with preferred vendors, ensuring alignment with approved pricing frameworks and study scope.
- Evaluate pricing across approved vendors, assessing cost drivers, service models, and operational considerations.
- Ensure scope accuracy by eliminating duplicate services, clarifying responsibilities, and aligning deliverables with existing MSAs.
- Partner with Clinical Operations to identify scope changes and incorporate updates into budgets and contract documentation.
Contract Negotiation & Execution
- Negotiate scope, pricing adjustments, assumptions, and contract terms within established MSA guidelines.
- Draft, review, and execute Statements of Work (SOWs), amendments, change orders, and closeout agreements.
- Drive vendors to meet established Vendor Sourcing Timelines (VSTs).
- Ensure contracts comply with ICH GCP guidelines, internal procurement policies, and applicable regulatory requirements.
- Maintain complete documentation to support audit and inspection readiness.
- Identify recurring pricing, scope, or vendor performance trends and communicate findings to Category Management.
Commercial Compliance & Governance
- Ensure all SOWs and amendments comply with approved MSAs, rate cards, and pricing governance standards.
- Apply Fair Market Value (FMV) methodologies and financial controls to validate vendor proposals.
- Maintain accurate documentation within contracting systems and document repositories.
- Support audit readiness through clear documentation and defensible commercial decision-making.
- Collaborate with cross-functional stakeholders to ensure consistent contract governance and compliance.
Qualifications
- Experience managing complex clinical vendor categories, including CROs, central laboratories, clinical technology providers, or similar service partners.
- Strong background in specification development, scope validation, and vendor budget development.
- Proven experience negotiating pricing, scope, and contract terms within established Master Service Agreement (MSA) frameworks.
- Thorough understanding of end-to-end clinical trial contracting processes and study start-up timelines.
- Strong commercial and financial acumen with the ability to identify pricing discrepancies, scope overlap, and contractual risk.
- Experience managing vendor performance against contracting timelines and operational milestones.
- Excellent organizational skills with the ability to manage multiple complex contracts simultaneously.
- Strong stakeholder management and cross-functional collaboration skills.
- Detail-oriented with a strong focus on compliance and process governance.
- Excellent written and verbal communication skills.
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