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.