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Clinical Research Associate

1-3 years
Not Disclosed
10 July 1, 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 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.