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    Senior Manager :Clinical Outsourcing

    Sun Pharma
    5+ years
    Not Disclosed
    Bangalore
    10 Jan. 5, 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
    Date: December 15, 2024
    Location: Mahakali Office, Mumbai
    Company: Sun Pharmaceutical Industries Ltd

    Sun Pharma is one of the world’s leading pharmaceutical companies, providing high-quality medicines across Specialty, Generics, and Consumer Healthcare categories. With a global presence in over 100 countries and backed by more than 40 manufacturing facilities, Sun Pharma is committed to improving healthcare access and outcomes.

    Position Summary

    Sun Pharma is seeking a Senior Manager, Clinical Outsourcing to join its dynamic team at the Mahakali Office. This role involves overseeing clinical trial outsourcing, vendor management, contract negotiation, and budget analysis to support Sun Pharma's clinical development programs. The position requires close collaboration with project teams, CROs, and vendors, ensuring that clinical trial activities adhere to corporate policies and regulations while meeting quality and timeliness expectations.

    Key Responsibilities

    1. Support Outsourcing Team (30%)

    • Locate and organize Statements of Work (SOW) for study-level agreements, ensuring final contracts and working documents are stored systematically in the Clinical Outsourcing folder.
    • Maintain consistent naming conventions for all documents.
    • Review CRO contracts and compile category spend data for analysis.
    • Liaise effectively with project teams, CROs, and vendors to ensure seamless communication and operations.
    • Search and manage documents in the Contract Management System.
    • Create and maintain Vendor Contract Trackers for each study, ensuring they are updated with contract data and terms.
    • Collect and analyze data from CRO contracts to support decision-making.
    • Establish outsourcing onboarding guidelines and develop standardized templates for team use.
    • Design and maintain cost-saving Excel tools.
    • Assist in creating clinical trial budgeting models and scenario analyses for future trials.
    • Support FP&A activities, including annual budgeting, periodic forecasting, and monthly budget-versus-actual analysis for clinical vendors.

    2. Vendor Management (25%)

    • Schedule, organize, and facilitate kickoff meetings with vendors and participate in team meetings to ensure alignment.
    • Support project teams in maintaining the quality and timeliness of outsourced deliverables.
    • Monitor and manage relationships with contracted vendors, resolving issues and conflicts efficiently.
    • Support governance activities and ensure smooth communication between vendors and internal teams.
    • Work with project teams to ensure that clinical trial activities comply with corporate SOPs, guidelines, and regulations.
    • Ensure vendor accountability by identifying issues and developing actionable solutions.
    • Oversee the closure of studies/contracts with vendors, including mutual performance evaluations.

    3. Vendor Selection and Contract Negotiation (35%)

    • Guide project teams through the outsourcing process, providing expert advice on best practices.
    • Evaluate, select, and negotiate contracts for assigned studies/programs.
    • Collaborate with Project Managers and teams to develop and execute RFPs.
    • Support operational, scheduling, and budget considerations during the vendor selection process.
    • Develop Statements of Work (SOW) in coordination with project teams, ensuring thorough review and finalization.
    • Negotiate work specifications, budgets, payment schedules, and performance management plans to ensure optimal vendor performance.

    Qualifications and Skills

    • Proven experience in clinical outsourcing, vendor management, and contract negotiation.
    • Expertise in forecasting, budgeting, data analytics, and financial modeling.
    • Strong knowledge of CRO/vendor oversight, clinical trial operations, and regulatory requirements.
    • Exceptional interpersonal, communication, and problem-solving skills.
    • Familiarity with Contract Management Systems and advanced Microsoft Excel proficiency.
    • Ability to work collaboratively across functions and build strong relationships with stakeholders.

    Core Competencies

    • Strategic thinking and decision-making capabilities.
    • Excellent organizational and analytical skills.
    • Ability to thrive in a fast-paced environment and manage multiple vendors (15–25 per study).
    • High integrity and commitment to maintaining quality standards.

    Compensation and Benefits

    This position offers competitive compensation, performance-based bonuses, and access to Sun Pharma’s comprehensive employee benefits, including health insurance, retirement plans, and paid time off.

    Equal Opportunity Employer

    Sun Pharma is an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Discrimination based on race, religion, gender, disability, or any other legally protected category is strictly prohibited.

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