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    Manager - 2 Global Trial Manager

    Sun Pharma
    6+ 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

    Here’s a rewritten version of the job description for clarity, readability, and professionalism:

    Job Title:

    Global Trial Manager – Clinical Operations

    Company Overview:

    Sun Pharma is the world's fourth-largest specialty generics company, offering a diverse portfolio across Specialty, Generics, and Consumer Healthcare products. With over 40 manufacturing facilities worldwide, we deliver high-quality medicines trusted by healthcare professionals and patients in over 100 countries. Over the past two decades, Sun Pharma has become a market leader in generics in the U.S. and India, while rapidly expanding its specialty branded market presence with a focus on dermatology, ophthalmology, and onco-dermatology.

    Job Description:

    Location: Mumbai, India
    Department: Clinical Development
    Reports To: Global Trial Leader, Clinical Operations

    Sun Pharma is seeking a Global Trial Manager to join its Clinical Development Team. This role will provide operational oversight for the management of global, regional, or complex local clinical trials. The Global Trial Manager will assist the Global Trial Leader in ensuring successful trial execution, from start-up to close-out, while maintaining compliance with protocols, timelines, and regulatory requirements.

    Key Responsibilities:

    Oversight of CROs, Vendors, and Study Management:

    • Supervise CRO pre-site selection, initiation, monitoring, close-out, and co-monitoring visits to ensure protocol and regulatory compliance and optimal site performance.
    • Manage CROs and other vendors, ensuring timely project deliverables and quality outcomes.
    • Monitor study progress, data quality, and operational timelines to ensure alignment with project goals.
    • Evaluate and manage project progress and resources to maintain budget adherence and timeline execution.
    • Oversee and review clinical trial documents, including protocols, amendments, informed consents, CRF design, and protocol-specific training materials.
    • Ensure proper Trial Master File (TMF) management and perform regular document reviews.
    • Utilize clinical trial management systems (CTMS, EDC, IVRS) to track study progress and review data for accuracy.
    • Collaborate with QA teams on CAPA documentation and resolution.
    • Assist in forecasting and requisitioning investigational products (IP) and in preparing and monitoring clinical trial budgets.

    Collaboration with Cross-Functional Teams:

    • Coordinate with cross-functional teams, including medical monitoring, regulatory affairs, supply chain, statistics, data management, QA, QC, and external vendors.
    • Provide administrative support for meetings, including investigator meetings and CRO/vendor kick-offs.
    • Facilitate effective communication between internal and external teams to ensure successful trial execution.

    Soft Skills and Industry Awareness:

    • Strong problem-solving and decision-making skills to navigate complex challenges.
    • Stay updated on industry trends, emerging therapies, and advancements in clinical trial methodologies.
    • Foster collaboration, teamwork, and a culture of continuous improvement and inclusion.

    Qualifications:

    • Experience:
      • Minimum of 6 years of clinical study management experience, including 2+ years in multinational study management.
      • At least 2 years of experience in dermatology.
      • Proven ability to manage CROs and clinical study vendors.
    • Education:
      • Bachelor’s degree in life sciences, pharmacy, or nursing.
    • Skills:
      • Robust understanding of ICH/GCP and regulatory requirements.
      • Proficiency in MS Office (Word, Excel, PowerPoint) and familiarity with EDC, CDMS, IRT systems.
      • Strong project management and organizational skills.
      • Excellent verbal and written communication skills.
      • Ability to work independently, prioritize tasks, and manage multiple responsibilities.

    Additional Information:

    • Travel: Approximately 10% domestic and international travel required.
    • Equal Opportunity Employer:
      Sun Pharma is an equal opportunity employer. All qualified applicants will receive consideration for employment without discrimination based on race, religion, color, national origin, sex, age, disability, veteran status, or any other status protected by law.

    This description outlines the general nature and level of work for this role. It is not exhaustive, and the employer reserves the right to modify duties as necessary.

    For more details, visit our careers website: https://www.sunpharma.com

    Let me know if you’d like further refinements!

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