Note: The job is a remote job and is open to candidates in USA. Hydrogen Group is seeking an experienced Clinical Program Sourcing & Contract Management Manager to support global Phase I-IV clinical trials. The role leads study-level contracting for clinical service providers, including vendor specification intake, budget development, negotiation, contract execution, compliance, and governance.
Responsibilities
- 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
- 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
- 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
Skills
- 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
- Location: Remote (U.S., Eastern Time preferred)
Benefits
- Remote (U.S., Eastern Time preferred)
- 4-Month Initial Contract
Company Overview