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Senior Manager :Clinical Outsourcing

5+ years
Not Disclosed
10 April 30, 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

 

Job Title:

Senior Manager: Clinical Outsourcing


Company:

Sun Pharmaceutical Industries Ltd


Location:

Mahakali - Office


Job ID / Posting Date:

Posted on April 10, 2025


Role Summary:

The Senior Manager, Clinical Outsourcing, will be responsible for managing and supporting the outsourcing process for clinical trials. This includes managing contracts with CROs and vendors, analyzing contract data, ensuring quality and timely deliverables, and negotiating contracts. The role requires strong communication, organizational, and negotiation skills to ensure smooth operations throughout the outsourcing process.


Key Responsibilities:

Clinical Outsourcing Support (30%):

  • Locate and manage Statement of Work (SOW) for each study-level agreement.

  • Ensure consistent naming conventions and save working documents and final contracts in the appropriate folders.

  • Review CRO contracts and categorize spend for analysis.

  • Liaise with project teams, CROs, and vendors.

  • Search the Contract Management System for relevant data.

  • Create and maintain Vendor Contract Trackers for each study.

  • Collect and analyze data from CRO contracts.

  • Assist in setting up Outsourcing Onboarding guidelines and cost-saving excel files.

  • Develop clinical trial budgeting models and conduct what-if scenarios for future trials.

  • Assist FP&A needs related to clinical vendors, including budgeting, forecasting, and budget vs. actual analysis.

Vendor Management (25%):

  • Participate in scheduling, organizing, and facilitating vendor kickoff meetings.

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

  • Manage relationships with vendors and resolve any issues or conflicts.

  • Ensure vendors/CROs are accountable and adhere to applicable Corporate SOPs, WPs, policies, guidelines, and regulations.

  • Facilitate the closure of studies/contracts with mutual performance assessments.

Vendor Selection & Contract Negotiation (35%):

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

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

  • Work with Project Managers to develop RFPs and support the selection process.


Qualifications:

  • Experience:

    • 5+ years in clinical outsourcing, project management, or vendor management.

    • Experience with CROs, vendor management, and clinical trial budgeting.

    • Strong understanding of outsourcing processes, contract negotiation, and vendor relations.

  • Skills:

    • Excellent communication, organizational, and negotiation skills.

    • Strong analytical skills for contract data analysis.

    • Ability to work collaboratively with project teams and external vendors.

    • Proficiency in Contract Management Systems and Excel.

  • Education:

    • Bachelor's degree in Life Sciences, Pharmacy, or a related field.


Additional Information:

This position provides an opportunity to play a key role in the outsourcing and vendor management aspects of clinical trials, with the responsibility to manage and negotiate contracts and ensure the delivery of quality services from external vendors.