Senior Clinical Research Associate (CRA)
Company: Bristol Myers Squibb (BMS)
Location: Mumbai, India
Job Type: Full-Time
Job Overview
Bristol Myers Squibb is seeking an experienced Senior Clinical Research Associate (CRA) to oversee the quality, compliance, and execution of clinical trials at investigational sites. The role serves as the primary site-level contact for internal and external stakeholders and ensures clinical studies are conducted in accordance with study protocols, ICH-GCP guidelines, SOPs, and regulatory requirements.
Key Responsibilities
Clinical Trial Monitoring
Conduct site qualification, initiation, routine monitoring, and close-out visits across clinical trial phases.
Ensure compliance with study protocols, SOPs, ICH-GCP guidelines, and regulatory requirements.
Verify accuracy, completeness, and integrity of clinical trial data.
Monitor patient safety and site compliance throughout study execution.
Site Management
Serve as the primary point of contact for investigative sites.
Build and maintain strong relationships with investigators, site staff, vendors, and cross-functional teams.
Support site enrollment, retention, and study performance objectives.
Assess site capabilities and identify potential new investigators and research sites.
Compliance & Quality Oversight
Ensure adherence to GCP, local regulations, and ALCOA data integrity principles.
Participate in sponsor audits and regulatory inspections.
Support development and implementation of Corrective and Preventive Actions (CAPA).
Assist with Ethics Committee submissions, informed consent reviews, and regulatory documentation.
Risk-Based Monitoring
Apply targeted, centralized, remote, and risk-based monitoring methodologies.
Identify and assess site-level and study-level risks.
Implement mitigation strategies and monitor risk indicators.
Analyze site performance metrics and adapt monitoring strategies accordingly.
Investigational Product Management
Review and oversee study drug/Investigational Medicinal Product (IMP) accountability and reconciliation.
Support study drug label translation activities when required.
Maintain oversight of study drug handling and documentation.
Study Operations Support
Coordinate site activities related to database lock and study closure.
Ensure timely completion of close-out activities.
Maintain accurate and up-to-date records in BMS and vendor systems.
Submit monitoring reports and administrative documentation within required timelines.
Leadership & Mentoring
Function independently and provide operational leadership at site level.
May act as Lead CRA for local studies.
Mentor and train junior CRAs and new team members.
Support onboarding and competency assessments.
Serve as Subject Matter Expert (SME) for:
Risk-Based Monitoring
Root Cause Analysis
CAPA Processes
Clinical Trial Monitoring Best Practices
Qualifications
Education
Bachelor's Degree in Life Sciences, Pharmacy, Biotechnology, Nursing, Medical Sciences, or related field.
Experience
Required
Minimum 5 years of Clinical Research Associate (CRA) monitoring experience.
Strong experience in site monitoring across clinical trial phases.
Experience working within pharmaceutical, biotechnology, sponsor, or CRO environments.
Knowledge of clinical development and drug development processes.
Demonstrated leadership, mentoring, and coaching capabilities.
Preferred
Prior experience with Pharma/Biotech Sponsor organizations.
Lead CRA experience.
Experience participating in regulatory inspections and audits.
Experience with risk-based monitoring approaches.
Uttar Pradesh :
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Remote, India | Siliguri |Illinois :
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