The Clinical Sourcing Manager provides strategic and operational support for outsourced Clinical, Clinical Pharmacology, and Nonclinical activities. This role serves as a subject matter expert in clinical outsourcing, overseeing vendor selection, contracting, budgeting, and performance to ensure high-quality execution of outsourced studies in compliance with regulatory and ethical standards.
Responsibilities
- Support and manage clinical outsourcing activities, including RFIs, RFPs, vendor selection, and contracting
- Review, analyze, and negotiate vendor proposals, budgets, rate cards, discounts, and rebates
- Develop and review Statements of Work, contracts, and change orders to ensure appropriate scope, quality, and financial terms
- Coordinate vendor governance, performance oversight, and quarterly business reviews
- Track study and project budgets, including budget vs. actuals, forecasts, and financial KPIs
- Maintain outsourcing documentation, contracts, and budgets within internal systems and tools
- Support invoice review, purchase order creation, and resolution of invoicing issues
- Partner with clinical teams to provide guidance on outsourced work, vendor performance, and contractual management
- Contribute to the development and continuous improvement of outsourcing templates, tools, and processes
- Ensure compliance with GCP, privacy regulations, and internal outsourcing and procurement policies
Qualifications
- Bachelor’s degree in Business, Finance, Life Sciences, Pharmacy, or related field; advanced degree preferred
- 10+ years of clinical outsourcing experience in the biotech or pharmaceutical industry
- Advanced knowledge of clinical trial costing, proposal analysis, and budget impact assessment
- Proven experience managing RFIs/RFPs, vendor negotiations, and contract execution
- Strong financial, spreadsheet, and forecasting skills; experience with outsourcing tools (e.g., ClearTrials) preferred
- Experience with purchase orders, change orders, and associated approval workflows
- Knowledge of GCP, Sunshine Act, GDPR, and applicable industry standards