US_Clinical Contracts Analyst III

Position: Clinical Program Sourcing & Contract Manager (CPSCM)

Location: Fully Remote ( EST Preferred)

Duration: 4-month contract

Pay Rate: $76.00 -$79.61/hour (W2)

Benefits: Weekly pay, medical, dental, and vision coverage



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 IIV).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.



Key Responsibilities
Specification Management & Budget Development

• 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.

Contract Negotiation & Execution

• 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

• 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.

Stakeholder & Vendor Management

• Serve as a trusted procurement and contracting partner to Clinical Operations and Study Teams.
• Establish strong working relationships with preferred clinical vendors and internal cross-functional stakeholders.
• Facilitate discussions between Clinical Operations, vendors, Finance, Legal, and Category Management to resolve complex contracting issues.
• Manage multiple high-value and time-sensitive contracts simultaneously while maintaining strong attention to detail.
• Communicate contracting status, risks, dependencies, and timeline impacts to appropriate stakeholders.
• Escalate issues proactively and recommend commercially sound solutions.
  
  

Qualifications

• 57+ years of relevant experience in clinical contracts, clinical sourcing, procurement, or a related clinical research environment .
• Demonstrated experience managing complex clinical vendor categories (e.g., CROs, central labs, clinical technology services ).
• Strong expertise in contract review, 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 understanding of clinical budgets , pricing structures, and financial terms.
• Strong commercial acumen and ability to identify pricing discrepancies, duplication of scope, and contract risk .
• Experience with contract auditing, change orders, and vendor negotiations .
• Experience driving vendors to meet contracting cycle times and operational milestones.
• Experience supporting global Phase IIV clinical trials .
• Experience working with preferred vendor networks and established MSA structures.
• CRO experience is preferred.
• Knowledge of ICH-GCP, clinical research regulations, and pharmaceutical procurement practices .
• Experience applying Fair Market Value (FMV) methodologies to clinical vendor proposals.
• Familiarity with clinical contracting, sourcing, procurement, or financial management systems.
• Experience supporting audits, inspections, and regulated documentation environments .
• Previous experience working cross-functionally with Clinical Operations, Finance, Legal, Procurement, and Category Management .
• Bachelors degree in Business, Finance, Supply Chain, Life Sciences, Clinical Research, Procurement, or a related field preferred.
• Highly organized with the ability to manage multiple complex contracts concurrently.
• Strong stakeholder management and cross-functional collaboration skills.
• Detail-oriented with a disciplined compliance mindset.
• Excellent written and verbal communication skills.

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