Senior Manager, Clinical Outsourcing

Title: Senior Manager, Clinical Outsourcing

Sun Pharma is the world’s fourth largest specialty generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology.

Sun is seeking a Senior Manager, Clinical Outsourcing within its Clinical Outsourcing Team in Princeton, NJ. The Senior Manager, Clinical Outsourcing will report into Sr. Director, Clinical Outsourcing. Under the direction of the Senior Director, Clinical Outsourcing, the Senior Manager, Clinical Outsourcing will lead and manage the clinical trial outsourcing, vendor selection and contract negotiation, vendor management, and reporting process for Sun Pharmaceutical’s clinical development programs.

This role will be Instrumental in the management of external partnership outcomes for clinical trials, including coordination and management of service providers and other outsourcing needs. Responsibilities include clinical CRO/vendor identification, RFI/RFP development and execution, vendor selection, contract negotiations, budget management and service provider performance metrics development and tracking.

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.
• 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.

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.

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…