Senior Manager, Clinical Outsourcing

Responsibilities

• Vendor selection and contract negotiation:
• Guides project teams through the outsourcing process and gives appropriate suggestions and advice on the best approach / best practices
• Guides and participates in the evaluation, selection, and negotiation of contracts for assigned studies/programs
• Works with Project Managers and Project Teams to develop RFPs
• Works with Project Managers and Project Teams for all operational, scheduling, project budget and cost-saving considerations for assigned studies/programs
• Liaises with project teams to develop the Statement of Work (SOW) for each contract; coordinates the SOW review and finalization process
• Negotiates new and amended work specifications, budgets, payment schedules, relationship management plans, and other documents that control the activities and performance of contract service providers
• Vendor management: 15 – 25 Vendor per study
• Participates in scheduling, organizing, and facilitating kickoff meetings with vendors
• Participates team meetings with vendors
• Supports the project teams to assure the quality and timeliness of deliverables through outsourcing
• Maintains and manages relationships with contracted vendors; facilitates the resolution of issues and conflicts
• Supports organizational governance activities with vendors
• Ensures outsourced clinical trial activities meet quality standards and expectations and adhere to applicable Corporate SOPs, WPs, policies, guidelines, and regulations
• Ensures smooth and effective communication between the vendors and the company
• Ensures Vendors/CROs are accountable and Identifies issues and develop solutions
• Facilitates the closure of each study/contract with the vendor, including a mutual assessment of performance
• Support Outsourcing Team
• Locate Statement of Work (SOW) for each study level agreement; save the working documents as well as final contracts to the Clinical Outsourcing folder
• Ensure consistent naming convention
• Review CRO Contract & populate category spend to allow for analysis
• Ability to Liaise with project teams, CROs and Vendors
• Ability to search Contract Management System
• Create Vendor Contract Trackers for each study and update with contract data and terms
• Collect and analyze data from CRO contracts
• Setup Outsourcing Onboarding guidelines
• Support the development of templates and save to Outsourcing folders
• Setup cost-saving excel file
• Aid in creating clinical trial budgeting models and what-if scenarios for future trials
• Aid in FP&A needs related to clinical vendors, including annual budgeting, periodic forecasting, and monthly budget vs. actual analysis
• Cross-Functional Support
• Aid in creating clinical trial budgeting models and what-if scenarios for future trials
• Aid in FP&A needs related to clinical vendors, including annual budgeting, periodic forecasting, and monthly budget vs. actual analysis

Qualifications

• BA or MS in relevant discipline
• Minimum of 5 years clinical outsourcing experience

Pay

The presently-anticipated base compensation pay range for this position is $121,500 to $174,000. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience.