Clinical Trial Associate

2+ years

Not Disclosed

Mumbai

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.

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Clinical Trial Associate

Job Description

Job Description:

Key Responsibilities:

Qualifications:

About Bristol Myers Squibb:

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