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Senior Manager :Clinical Outsourcing

2+ years
Not Disclosed
10 April 22, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Manager : Clinical Outsourcing
Position: Senior Manager
Location: Mahakali - Office
Company: Sun Pharmaceutical Industries Ltd

Job Summary:
Sun Pharmaceutical is seeking a Senior Manager, Clinical Outsourcing, responsible for overseeing the outsourcing of clinical trials and managing vendor relationships. The role will focus on contract management, vendor selection, budgeting, and providing support to project teams. The Senior Manager will also assist in negotiating contracts, analyzing CRO data, and ensuring timely and quality deliverables from vendors.

Responsibilities:

30% Support Outsourcing Team:

  • Locate Statement of Work (SOW) for each study-level agreement; save working documents and final contracts to the Clinical Outsourcing folder.

  • Ensure consistent naming conventions for all contracts.

  • Review CRO contracts and populate category spend for analysis.

  • Liaise with project teams, CROs, and vendors to maintain smooth operations.

  • Search the Contract Management System to retrieve relevant contract information.

  • Create and maintain Vendor Contract Trackers for each study, updating with contract data and terms.

  • Collect and analyze data from CRO contracts to assess performance and identify cost-saving opportunities.

  • Assist in the setup of Outsourcing Onboarding guidelines.

  • Support the development of templates and save them to Outsourcing folders.

  • Set up cost-saving Excel files and assist with creating clinical trial budgeting models.

  • Create "what-if" scenarios for future trials and assist with FP&A needs, including annual budgeting, forecasting, and monthly budget vs. actual analysis.

25% Vendor Management (15-25 Vendors per Study):

  • Participate in scheduling, organizing, and facilitating kickoff meetings with vendors.

  • Participate in team meetings with vendors to ensure smooth execution.

  • Support project teams to ensure the quality and timeliness of deliverables.

  • Monitor and manage relationships with contracted vendors, resolving issues and conflicts.

  • Assist with organizational governance activities related to vendors.

  • Work with Project Teams to ensure outsourced clinical trial activities meet quality standards and adhere to applicable Corporate SOPs, WPs, policies, guidelines, and regulations.

  • Ensure effective communication between vendors and the company, ensuring vendors/CROs are accountable.

  • Identify issues, develop solutions, and facilitate the closure of each study/contract with the vendor, including mutual performance assessments.

35% Vendor Selection and Contract Negotiation:

  • Guide project teams through the outsourcing process, offering advice on best practices.

  • Participate in the evaluation, selection, and negotiation of contracts for assigned studies/programs.

  • Collaborate with Project Managers and Project Teams to develop RFPs.

Qualifications:

  • Proven experience in clinical outsourcing, vendor management, and contract negotiation.

  • Strong ability to manage vendor relationships and ensure timely, quality deliverables.

  • In-depth understanding of clinical trial processes, budgets, and contract management systems.

  • Strong communication skills and the ability to work cross-functionally with internal teams and external vendors.