Document Coordinator, Global Trial Acceleration
Location: Hyderabad, TS, India
Department: Clinical Development & Operations
About Bristol Myers Squibb (BMS)
At Bristol Myers Squibb, we are driven by a single vision: "Transforming patients' lives through science." Our work is challenging, meaningful, and life-changing, impacting both patients and the careers of those who drive medical innovation. Join us to thrive in an environment that fosters growth, diversity, flexibility, and collaboration.
Learn more: careers.bms.com/working-with-us.
Position Summary
The Document Coordinator, Global Trial Acceleration is responsible for the collection, compilation, review, and approval of clinical trial-related documents across all phases of global clinical trials. The role involves engaging with investigators, study teams, CROs, and regulatory bodies to ensure compliance with BMS standards and regulatory guidelines. Additionally, the role includes reviewing Site Monitoring Visit reports, identifying issues, and ensuring timely resolution.
Key Responsibilities
Clinical Trial Document Management:
Manage and execute centralized document-related activities for global clinical trials.
Serve as the primary point of contact for essential document management, regulatory submissions, and compliance tracking.
Initiate and manage start-up documentation activities for clinical trials.
Ensure timely collection, review, approval, and maintenance of country- and site-level documents.
Regulatory & Ethical Submissions:
Support regulatory submission activities, including Institutional Review Board (IRB) and Independent Ethics Committee (IEC) approvals.
Submit potential investigators for debarment review and track decisions.
Provide quality control (QC) oversight on study start-up documentation.
Clinical Site Activation & Monitoring:
Responsible for country/site activation processes, ensuring compliance with applicable study procedures.
Review and approve essential documents before first patient enrollment.
Centrally review Site Monitoring Visit reports, identify issues, escalate as needed, and ensure resolution.
Assist with Investigator Site File (ISF) and pharmacy file creation.
System & Process Management:
Maintain and update clinical trial management systems (CTMS, Veeva Vault, eTMF, SharePoint, etc.).
Arrange certified translations of study documents (e.g., Informed Consent Forms, Protocols, Investigator Brochures).
Support Clinical Study Reports (CSR) appendices and distribution.
Collaboration & Stakeholder Engagement:
Work closely with Country Trial Managers (CTMs), Clinical Research Organizations (CROs), and Clinical Trial Monitors (CTMo).
Develop strong relationships with internal teams to drive study efficiency.
Contribute to the standardization and improvement of clinical documentation processes.
Qualifications & Experience
Education:
Bachelor’s degree in Life Sciences, Business Administration, Legal Studies, or equivalent field.
Advanced degree (e.g., MSc, MBA) is a plus.
Experience:
3+ years of experience in clinical research, document coordination, or regulatory affairs in Pharma, Biotech, or CRO environments.
Strong knowledge of ICH-GCP, regulatory requirements, and clinical trial processes.
Prior experience in global clinical trial site monitoring is preferred.
Familiarity with clinical document management systems (CTMS, eTMF, Veeva Vault).
Expertise in therapeutic areas such as Oncology, Cardiology, Hematology, or Immunology is a plus.
Key Competencies:
Regulatory Knowledge: Understanding of global clinical trial documentation requirements.
Attention to Detail: Strong ability to review and validate trial documents with precision.
Stakeholder Management: Ability to collaborate with global teams, investigators, and regulators.
Time Management: Ability to prioritize tasks and meet critical deadlines.
Technical Skills: Proficiency in MS Office Suite, SharePoint, CTMS, eTMF, and database systems.
Language: Strong English written and verbal communication skills.
Why Join BMS?
Impactful Work: Contribute to cutting-edge clinical trials that improve patient outcomes worldwide.
Career Growth: Access diverse learning opportunities in a collaborative global environment.
Flexible Work Culture: Benefit from work-life balance and remote flexibility.
Competitive Benefits: Enjoy a robust compensation package, health benefits, and professional development support.
Join us in transforming patients’ lives through science!
How to Apply:
Interested candidates can apply at careers.bms.com or contact adastaffingsupport@bms.com for application accommodations.
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