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Clinical Trial Associate

Bristol Myers Squibb
Bristol Myers Squibb
2+ years
Not Disclosed
10 March 6, 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

 

Clinical Trial Associate

Company: Bristol Myers Squibb
Location: Mumbai, Maharashtra, India
Job ID: R1589877
Updated: Today

Job Description:

Key Responsibilities:

  • Manage study start-up and ongoing document management.
  • Serve as the point of contact for local study teams and external stakeholders.
  • Oversee study and site-level deliverables during start-up and maintenance.
  • Plan and strategize start-up activities to ensure trial milestones are met.
  • Review and approve essential clinical trial and regulatory documents.
  • Support local regulatory submissions for Health Authorities and Ethics Committees, including amendments.
  • Collaborate with internal teams for country feasibility and site selection.
  • Develop and manage country Informed Consent Form (ICF) templates.
  • Ensure the electronic Trial Master File (eTMF) is updated with regulatory documents.
  • Conduct drug/IMP label reviews and translations when applicable.
  • Stay updated on evolving country regulatory requirements in collaboration with Regulatory and Legal teams.
  • Assist with document collection and distribution, including insurance certificates.
  • Support Health Authority inspections, audits, and corrective action plans.

Qualifications:

  • Education: Bachelor's degree in Life Sciences or related field.
  • Experience: Minimum 2 years of industry-related experience.
  • Skills & Knowledge:
    • Strong understanding of GCP, ICH Guidelines, and country regulatory requirements.
    • Knowledge of clinical research processes, regulations, and methodologies.
    • Excellent organizational, time management, and decision-making skills.
    • Ability to manage multiple priorities and analyze risks effectively.
    • Strong verbal and written communication skills in English and the local language.

About Bristol Myers Squibb:

  • Committed to transforming patients’ lives through science.
  • Encourages diversity and inclusion in clinical trials.
  • Offers flexible work models based on role requirements.
  • Provides reasonable accommodations for applicants with disabilities.