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    Associate Global Trial Manager

    Bristol Myers Squibb
    2 years
    Not Disclosed
    Hyderabad
    12 Nov. 23, 2024
    Job Description
    Job Type: Full Time Education: BA/BS or equivalent degree 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 Description: PHASE IV Associate Global Trial Manager

    Division: Research and Development
    Functional Area: Global Trial Management

    About Working with Us

    At Bristol Myers Squibb, we believe in doing work that is:

    • Challenging: Driving operational excellence and clinical innovation.
    • Meaningful: Impacting patients' lives through cutting-edge research.
    • Life-changing: Transforming careers and the future of medicine.

    Our inclusive culture fosters collaboration and growth, offering a supportive environment with flexibility and a variety of benefits to help employees thrive professionally and personally.

    Learn more at: careers.bms.com/working-with-us.

    Position Summary / Objective

    The Associate Global Trial Manager provides operational support for global clinical trials, focusing on:

    • Trial Phases: Non-Registrational Data Generating or Registrational Data Generating interventional studies.
    • Scope of Responsibility: Trials in maintenance or close-out phases.
    • Project Management: Supporting study execution, managing issues, and ensuring quality oversight of internal teams and external vendors.

    Position Responsibilities

    Project Management:

    • Utilize performance metrics and quality indicators for study execution.
    • Oversee clinical monitoring quality and ensure adherence to study plans.
    • Collaborate with stakeholders to manage timelines, budgets, and deliverables.
    • Identify potential risks, implement mitigation strategies, and manage trade-offs.
    • Maintain project management tools (e.g., action logs, risk management plans).

    Study Planning and Conduct:

    • Oversee TMF (Trial Master File) set-up, review, and reconciliation.
    • Provide operational input into study documents, including protocols, case report forms (CRFs), and clinical study reports (CSRs).
    • Coordinate training for study teams, investigational sites, and vendors.
    • Support country and site feasibility/selection and recruitment/retention strategies.
    • Manage data review, protocol deviations, and study-specific trackers.
    • Participate in audit responses, CAPA (Corrective and Preventative Actions), and inspections.
    • Review vendor invoices and manage financial forecasting and budgets.

    Leadership:

    • Foster collaboration across teams and geographies.
    • Guide and mentor Global Trial Specialists (GTS).
    • Motivate teams, maintain composure during uncertainty, and encourage optimism.

    Qualifications

    Educational Requirements:

    • BA/BS or equivalent degree in a relevant discipline.

    Experience Requirements:

    • Minimum 2 years of clinical study management or equivalent experience.
    • Project management experience in the pharmaceutical or healthcare industry.
    • Familiarity with CTMS systems (preferred).

    Technical Competencies:

    • Knowledge of ICH/GCP guidelines, regulatory directives, and clinical research processes.
    • Proficiency with Microsoft applications (Word, Excel, PowerPoint).

    Key Competencies:

    • Ability to manage multiple deliverables, adapt to changing priorities, and make data-driven decisions.
    • Strong interpersonal, influencing, and cross-functional collaboration skills.

    Why You Should Apply

    • Join a team that embodies passion, innovation, urgency, accountability, inclusion, and integrity.
    • Work in an environment committed to fostering diversity and inclusion in clinical trials.
    • Opportunity to work on projects that transform lives—yours and those of patients worldwide.

    If this role aligns with your interests and you’re eager to grow, we encourage you to apply—even if your experience doesn’t perfectly match the requirements. You might be closer than you think to your next life-changing career opportunity.

     

     

     

     

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