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    Document Coordination Manager, Global Trial Acceleration

    Bristol Myers Squibb
    5-7 years
    preferred by company
    10 Nov. 23, 2024
    Job Description
    Job Type: Full Time Education: (BA or BS) in Legal, Life Sciences, Business Administration, 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

    Working with Us
    At Bristol Myers Squibb, every role is more than a job; it’s life-changing. Our work transforms patient lives and the careers of those who make it possible. Whether it's optimizing production or advancing cell therapy, our mission inspires us daily. Join high-performing, diverse teams and achieve growth opportunities of unmatched scale and scope.

    Why BMS?

    • Balanced, flexible work environment.
    • Competitive benefits, services, and programs to support personal and professional goals.
    • Read more: careers.bms.com/working-with-us.

    About BMS Hyderabad
    BMS Hyderabad is a global innovation hub focused on creating sustainable solutions to help patients prevail over serious diseases. This center supports groundbreaking technology and drug development activities to drive the next wave of innovation.

    Position Summary

    The Document Coordination Manager plays a critical role in document creation and CTA package management for all BMS clinical trials. This role involves collaborating with clinical trial vendors across various service categories and engaging closely with internal and external stakeholders to support trial activities.

    Key Responsibilities

    Centralized Clinical Trial Document Management

    • Manage and execute global trial documentation activities.
    • Develop collaborative relationships with clinical investigative sites.
    • Ensure compliance with regulatory standards, ethical practices, and BMS policies.

    Global Start-Up Documentation Activities

    • Generate, process, track, and distribute Confidential Disclosure Agreements (CDAs).
    • Assist in creating and distributing feasibility questionnaires and compiling feedback.
    • Submit potential investigators for debarment reviews.
    • Review regulatory documentation and resolve outstanding issues.
    • Submit finalized documents to the electronic Trial Master File (eTMF).

    Site Activation and Maintenance

    • Conduct site activation by reviewing applicable documents and completing site activation checklists.
    • Provide quality control of start-up activities.
    • Maintain and update clinical systems (e.g., CTMS, eTMF).

    Translation and Document Creation

    • Coordinate translation of study-level documents (e.g., ICFs, protocols, Investigator Brochures).
    • Assist with the creation of site-specific materials, such as pharmacy or Investigator site files.

    Ongoing Documentation Support

    • Communicate with sites and study teams for centralized study activities.
    • Manage external correspondence with investigative sites, including updates and approvals.
    • Support Central IRB/IEC processes, including submission and tracking of safety events.
    • Perform regular QC of eTMF to ensure accuracy and completeness.

    Financial and Template Management

    • Ensure adherence to global processes for collecting and reviewing Financial Disclosure Forms.
    • Create and manage standardized document templates.

    Additional Responsibilities

    • Lead or assist in generating CSR appendices.
    • Perform other duties as assigned to support clinical trials.

    Qualifications and Experience

    Education

    • Bachelor’s Degree (BA or BS) in Legal, Life Sciences, Business Administration, or equivalent.
    • Advanced degree preferred.

    Experience

    • 5–7 years of clinical development experience in pharma, biotech, CRO, or similar industries.
    • Proven knowledge of ICH/GCP guidelines and the drug development process.

    Skills

    • Proficiency in MS Office Suite, SharePoint, CTMS (Veeva preferred), and clinical trial databases.
    • Strong organizational, time-management, and analytical skills.
    • Ability to manage and influence cross-functional, multi-cultural teams.
    • Flexibility to adapt to a dynamic and complex work environment.
    • Excellent stakeholder management skills with a proven ability to incorporate feedback.

    Personal Attributes

    • High adaptability in ambiguous situations.
    • Strong decision-making and problem-solving skills.
    • Ability to prioritize and balance multiple tasks effectively.

    Join Us

    Take your career further than you thought possible with Bristol Myers Squibb.

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