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Senior Clinical Research Associate

Novartis
Novartis
4+ years
Not Disclosed
Delhi, Mumbai, India
1 May 6, 2026
Job Description
Job Type: Full Time Education: Bachelor’s Degree or Master’s Degree in: Life Sciences Pharmacy Biotechnology Nursing Medicine Clinical Research Healthcare Sciences Or equivalent scientific disciplines Skills: Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trial Management Systems, Clinical Trials, Collaboration, Data Integrity, Decision Making Skills, Lifesciences

Senior Clinical Research Associate (sCRA)

Locations: Delhi (Office) & Mumbai (Head Office)
Job Type: Full-Time
Experience Required: Minimum 4+ Years in Clinical Research or Pharmaceutical Industry
Application Deadline: May 7, 2026
Industry: Pharmaceutical / Clinical Research / Healthcare


Job Overview

We are hiring an experienced and detail-oriented Senior Clinical Research Associate (sCRA) to manage and monitor clinical trial activities across investigational sites while ensuring compliance with regulatory guidelines, patient safety standards, and clinical research protocols.

The ideal candidate will independently oversee Phase I–IV clinical trial sites, conduct monitoring visits, support audit readiness, and collaborate with global clinical teams to ensure successful trial execution. This role is well-suited for professionals with strong expertise in clinical monitoring, ICH/GCP compliance, site management, and clinical operations.


Role Summary

The Senior Clinical Research Associate serves as the primary point of contact for assigned clinical trial sites and is responsible for maintaining high-quality site performance, ensuring data integrity, and driving regulatory compliance throughout the clinical trial lifecycle.

The role involves both on-site and remote monitoring activities while working closely with investigators, healthcare professionals, and cross-functional global teams to support successful clinical trial delivery.


Key Responsibilities

Clinical Trial Monitoring

  • Conduct:
    • Site Initiation Visits (SIV)
    • Routine Monitoring Visits
    • Remote Monitoring Activities
    • Close-Out Visits
  • Monitor Phase I–IV clinical trial activities according to:
    • Monitoring Plans
    • ICH/GCP Guidelines
    • Regulatory Requirements
    • Organizational SOPs

Site Management & Compliance

  • Serve as the primary liaison between the organization and investigational sites.
  • Ensure investigators and site teams comply with:
    • Clinical protocols
    • Regulatory standards
    • Good Clinical Practices (GCP)
  • Monitor patient data, source documentation, and study records for accuracy and completeness.
  • Ensure proper maintenance of:
    • Site documentation
    • Essential regulatory files
    • Study Trial Master File (sTMF)

Risk Management & Quality Assurance

  • Identify site risks, protocol deviations, and operational issues proactively.
  • Implement corrective and preventive actions (CAPAs) within defined timelines.
  • Support audit and inspection readiness activities.
  • Maintain data integrity and ensure inspection-ready documentation standards.

Stakeholder Collaboration

  • Collaborate with:
    • Clinical Project Managers (CPMs)
    • CRA Managers
    • Medical Teams
    • Medical Science Liaisons (MSLs)
    • Cross-functional global clinical teams
  • Build strong partnerships with investigational sites to improve:
    • Patient recruitment
    • Site performance
    • Clinical trial execution quality

Required Qualifications

Educational Qualifications

Required Education:

  • Bachelor’s Degree or Master’s Degree in:
    • Life Sciences
    • Pharmacy
    • Biotechnology
    • Nursing
    • Medicine
    • Clinical Research
    • Healthcare Sciences
    • Or equivalent scientific disciplines

Preferred Certifications:

  • Clinical Research Certification
  • GCP Certification
  • Clinical Trial Management Certification
  • Regulatory Affairs Certification (preferred)