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Clinical Research Associate

0-2 years
₹5,00,000 – ₹8,00,000
10 June 15, 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
Location: Mumbai (Head Office)
Employment Type: Full-time
Application Deadline: July 14, 2025
Job Requisition ID: REQ-10054048

Job Description:
Join Novartis as a Clinical Research Associate and take the lead in ensuring patient safety, data accuracy, and regulatory compliance across clinical research sites. You will be the vital link between clinical trial sites and Novartis teams, helping execute Phase I-IV protocols and driving timely and efficient clinical operations.

Key Responsibilities:

  • Act as the primary liaison between Novartis and assigned study sites, ensuring collaboration, milestone achievement, and a sense of ownership.

  • Conduct Site Initiation Visits, train site personnel on trial protocols, amendments, and ensure continuous training as needed.

  • Perform regular site monitoring (both onsite and remote) and manage site activities in line with ICH/GCP, regulatory, and Novartis standards.

  • Identify deficiencies in site processes, engage in risk mitigation, and support continuous site improvement.

  • Partner with sites to enhance patient recruitment and retention, and optimize site performance and compliance.

  • Conduct Site Closeout activities in accordance with SOPs and ensure proper archiving and follow-up.

  • Collaborate with Clinical Project Managers, CRA Managers, MSLs, and other internal stakeholders to align on site development and patient recruitment strategies.

  • Support audit readiness, participate in inspections, and ensure corrective actions are completed on time.

  • Oversee the resolution of data queries, maintain Investigator Site File (ISF), and ensure the Trial Master File (sTMF) is up-to-date.

Essential Requirements:

  • Bachelor's degree or higher in a scientific or healthcare discipline (or 4-year degree with relevant healthcare experience).

  • Fluent in written and spoken English and the local language.

Preferred Skills and Competencies:

  • Clinical Monitoring

  • Clinical Research and Clinical Trial Management

  • Data Integrity and Decision Making

  • Proficiency with Clinical Trial Management Systems (CTMS)

  • Strong collaboration and communication skills

Diversity and Inclusion Statement:
Novartis is dedicated to creating a diverse and inclusive work environment. We are committed to representing the communities we serve and providing accommodations to individuals with disabilities. To request support during the recruitment process, email:
diversityandincl.india@novartis.com with your request and job requisition number.

Estimated Salary: ₹5,00,000 – ₹8,00,000 per annum (based on industry standards and experience)