Clinical Research Associate – Novartis Healthcare, Mumbai
Location: Mumbai, India | Experience Level: Entry to Mid-Level | Job ID: REQ-10054048
Work Mode: On-site | Job Type: Full-time | Employment Type: Regular
Job Summary:
Novartis is hiring a Clinical Research Associate (CRA) to monitor patient data, trial compliance, and site engagement across Phase I–IV clinical studies. As a frontline liaison between Novartis and investigational sites, the CRA ensures adherence to ICH-GCP, regulatory protocols, and trial milestones. This role is critical in ensuring subject protection, data integrity, and the successful execution of trials in India.
Key Responsibilities:
Act as the primary point of contact for clinical trial sites
Manage assigned sites for Phases I–IV in line with Novartis SOPs and the Monitoring Plan
Conduct Site Initiation Visits and continuous site monitoring (remote and on-site)
Provide training and retraining to site personnel throughout the trial lifecycle
Ensure compliance with protocol, regulatory, and ethical standards (IRB/EC, GCP, etc.)
Identify site process deficiencies and implement risk mitigation strategies
Collaborate with clinical teams, CRMA, MSLs, and CPMs to enhance recruitment and data quality
Handle site documentation and ensure updated eTMF and Investigator Site Files
Participate in audit and inspection readiness activities
Coordinate timely data entry and resolution of queries with site personnel
Required Skills & Qualifications:
Bachelor's degree in life sciences or a healthcare-related field
Proficiency in written and spoken English and local languages
Knowledge of ICH-GCP, IRB/IEC processes, and Health Authority regulations
Experience with clinical site monitoring and regulatory documentation
Strong communication, documentation, and organizational skills
Ability to travel for site visits as required
Perks & Benefits:
Competitive salary and benefits (not explicitly listed; inferred as per Novartis standards)
Continuous training and professional development
Work with global clinical operations teams
Inclusion in Novartis talent network for career growth
Supportive work culture focused on innovation and impact
Company Description:
Novartis Healthcare Pvt. Ltd. is a global pharmaceutical leader, advancing innovation in drug development and patient care. With a strong presence in India, Novartis empowers teams to drive clinical excellence and meaningful healthcare outcomes.
Work Mode:
On-site – Mumbai (Head Office)
Call to Action:
Ready to play a key role in global clinical trials?
Apply now to join Novartis as a Clinical Research Associate and contribute to the future of healthcare innovation.
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