Title:  Senior Manager :Clinical Outsourcing

30% 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.
• Assist with creating clinical trial budgeting models and what-if scenarios for future trials
• Assist with FP&A needs related to clinical vendors, including annual budgeting, periodic forecasting, and monthly budget vs. actual analysis

25% 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.
• Monitors and manages relationships with contracted vendors; facilitates the resolution of issues and conflicts.
• Supports organizational governance activities with vendors.
• Works with Project Teams to ensure outsourced clinical trial activities meet quality standards and expectations and adheres 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.

35% 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.