Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Senior Clinical Research Associate

Bristol Myers Squibb
5+ years
Not Disclosed
Mumbai, India
-10 June 15, 2026
Job Description
Job Type: Full Time Education: Bachelor’s or Master’s degree in Technical , Life Sciences , Biology, Biochemistry, Molecular Biology Skills: Causality Assessment, Clinical SAS Programming, Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance, Communication Skills, CPC Certified, Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, 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

Position Summary

The Senior Clinical Research Associate (CRA) serves as the primary site-level contact for internal and external stakeholders and is responsible for ensuring the quality, integrity, compliance, and successful execution of clinical trials. The role oversees site management activities in accordance with study protocols, ICH-GCP guidelines, company SOPs, and applicable regulatory requirements.


Key Responsibilities

1. Clinical Trial Site Management

Site Monitoring Activities

  • Conduct:
    • Site Qualification Visits (SQV)
    • Site Initiation Visits (SIV)
    • Routine Monitoring Visits
    • Close-Out Visits
  • Ensure compliance with:
    • Study Protocols
    • ICH-GCP Guidelines
    • Sponsor SOPs
    • Local Regulatory Requirements

Data Verification & Quality Assurance

  • Verify source data and study documentation.
  • Ensure:
    • Accuracy
    • Completeness
    • Consistency
    • Accessibility of trial data
  • Review both:
    • Electronic records
    • Paper-based records (where applicable)

Data Integrity Oversight

  • Ensure compliance with ALCOA principles:
    • Attributable
    • Legible
    • Contemporaneous
    • Original
    • Accurate
  • Monitor data quality and reliability throughout the study lifecycle.

2. Regulatory Compliance & Inspection Readiness

Compliance Management

  • Ensure site compliance with:
    • ICH-GCP
    • Local regulations
    • Sponsor requirements

Audit & Inspection Support

  • Participate in:
    • Sponsor audits
    • Regulatory inspections
    • Health Authority inspections

Corrective & Preventive Actions (CAPA)

  • Support:
    • Root Cause Analysis (RCA)
    • CAPA development
    • CAPA implementation and follow-up

Ethics Committee & Regulatory Support

  • Support:
    • Ethics Committee submissions
    • Informed Consent Form (ICF) reviews
    • Collection and submission of regulatory documents

3. Site & Investigator Relationship Management

Investigator & Site Selection

  • Assess investigator qualifications and site capabilities.
  • Conduct feasibility assessments.
  • Identify potential new investigators and sites.

Stakeholder Engagement

Build and maintain relationships with:

  • Investigators
  • Site personnel
  • Vendors
  • Internal cross-functional teams
  • External partners

Study Performance Management

  • Motivate sites to achieve:
    • Enrollment targets
    • Retention goals
    • Study milestones

4. Risk-Based Monitoring & Issue Management

Risk Assessment

  • Identify and prioritize:
    • Site-level risks
    • Study-level risks

Risk Mitigation

  • Implement mitigation strategies.
  • Monitor risk indicators and site performance metrics.

Monitoring Approaches

Demonstrate expertise in:

  • Risk-Based Monitoring (RBM)
  • Remote Monitoring
  • Centralized Monitoring
  • Targeted Monitoring

Performance Analytics

  • Analyze:
    • Site performance metrics
    • Operational trends
    • Data quality indicators
  • Adjust monitoring strategies based on findings.

5. Investigational Product (IP) Management

Drug Accountability

  • Review and reconcile:
    • Study drug inventories
    • Investigational Medicinal Products (IMPs)

Study Blind Protection

  • Perform Unblinded Site Monitor activities when required.
  • Maintain study blinding integrity.

Additional Responsibilities

  • Support study drug label translations when applicable.

6. Clinical Trial Systems & Documentation

Clinical Systems Management

Utilize and maintain:

  • Clinical Trial Management Systems (CTMS)
  • Electronic Data Capture (EDC) Systems
  • Electronic Trial Master File (eTMF)
  • Risk-Based Quality Management (RBQM) Platforms

Documentation & Reporting

  • Prepare:
    • Monitoring reports
    • Administrative reports
    • Site visit documentation
  • Ensure reports are:
    • Timely
    • Accurate
    • Objective
    • Regulatory compliant

Database Lock Activities

  • Coordinate site readiness for database lock.
  • Ensure timely resolution of outstanding queries.

Site Closure

  • Conduct study close-out activities.
  • Ensure all protocol-required activities are completed.

7. Leadership & Mentoring

Team Support

  • Serve as a mentor and trainer for junior CRAs.
  • Provide technical guidance and coaching.

Subject Matter Expertise

Act as SME in:

  • Risk-Based Monitoring
  • Root Cause Analysis
  • CAPA Processes
  • Clinical Monitoring Best Practices

Training Responsibilities

  • Support CRA onboarding.
  • Conduct competency assessments.
  • Deliver formal and informal training programs.

Lead CRA Responsibilities

When assigned:

  • Serve as Lead CRA for local studies.
  • Manage operational deliverables and study outcomes.
  • Assist in resolving complex site and country-level issues.

Educational Qualification

Required

  • Bachelor's Degree (preferably in Life Sciences or related field)

Experience Requirements

Required

  • Minimum 5 years of Clinical Research Monitoring experience.
  • Strong performance across all aspects of CRA responsibilities.
  • Experience in:
    • Pharmaceutical Industry
    • Biotechnology Industry
    • Clinical Research Organizations (CROs)

Preferred

  • Sponsor-side clinical research experience.
  • Experience in drug discovery and development processes.
  • Previous mentoring or leadership experience.

Technical Competencies

Clinical Research Knowledge

  • Clinical Trial Operations
  • Clinical Monitoring
  • Protocol Compliance
  • Site Management
  • Patient Safety

Regulatory Knowledge

  • ICH-GCP Guidelines
  • Clinical Trial Regulations
  • Local Regulatory Requirements
  • Ethics Committee Processes

Data & Risk Management

  • Risk-Based Monitoring (RBM)
  • Data Integrity Management
  • Root Cause Analysis (RCA)
  • CAPA Management

Technology Proficiency

  • Microsoft Office Suite
  • CTMS Platforms
  • EDC Systems
  • eTMF Systems
  • RBQM Tools

Common Platforms

  • Veeva
  • Medidata
  • CluePoints

Core Competencies

Analytical & Problem-Solving

  • Critical Thinking
  • Risk Assessment
  • Data Analysis
  • Trend Identification

Communication Skills

  • Strong verbal communication
  • Strong written communication
  • Stakeholder engagement skills

Relationship Management

  • Investigator management
  • Site relationship building
  • Vendor collaboration
  • Cross-functional teamwork

Personal Attributes

  • High degree of autonomy
  • Adaptability and learning agility
  • Attention to detail
  • Results-oriented mindset
  • Strong organizational skills
  • Effective time management

Work Environment & Travel

Work Model

Depending on organizational assignment:

  • Site-Essential (100% Onsite)
  • Site-by-Design (Hybrid)
  • Field-Based
  • Remote-by-Design

Travel Requirements

  • Frequent travel may be required based on:
    • Assigned study sites
    • Geographic territory
    • Monitoring responsibilities

Ideal Candidate Profile

An experienced Clinical Research Associate with strong expertise in site monitoring, regulatory compliance, risk-based monitoring, and clinical trial operations, capable of independently managing multiple studies while providing leadership, mentorship, and operational excellence across diverse therapeutic areas.