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Senior Clinical Research Associate

3+ years
₹12–18 LPA
10 July 28, 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

Senior Clinical Research Associate
Location: Mumbai or Bangalore, India
Job ID: REQ-10058293
Date Posted: July 24, 2025
Employment Type: Full-Time, Regular
Shift: Day Shift
Division: Development
Business Unit: Universal Hierarchy Node
Company: Novartis Healthcare Private Limited


Job Summary:
As a Senior Clinical Research Associate (CRA) at Novartis, you will be the primary liaison between clinical trial sites and Novartis. Your role ensures the efficient and compliant execution of Phase I-IV Global Drug Development (GDD) trials. You’ll proactively manage site performance, address site needs, and ensure strict adherence to ICH/GCP guidelines, local regulations, and Novartis SOPs.


Key Responsibilities:

  • Act as the frontline liaison with trial sites, ensuring strong collaboration and ownership for site milestones and deliverables.

  • Conduct site monitoring activities (remote and on-site) for Phase I–IV trials, from initiation to closeout.

  • Ensure training of site staff during Site Initiation Visits (SIVs), protocol amendments, and staff changes.

  • Oversee compliance with protocols, ICH/GCP, and Health Authority requirements including documentation as per Novartis standards.

  • Identify and mitigate risks at site level; collaborate with stakeholders to promote compliance and quality culture.

  • Support early engagement for patient inventory planning and flow pre-SIV, in alignment with study teams.

  • Participate in audit readiness and inspection preparation, ensuring timely implementation of corrective actions.

  • Ensure timely query resolution and data accuracy in collaboration with internal and external stakeholders.

  • Maintain up-to-date Investigator Site Files (ISF) and ensure accurate Trial Master File (sTMF) documentation.

  • Work with cross-functional stakeholders (CRMA, MSL, Medical Advisor, Site Partnership Manager, etc.) to enhance site engagement and data quality.


Minimum Requirements:

  • Degree in scientific/healthcare field or equivalent experience (For U.S., 4-year degree + related experience).

  • Fluent in English and local language.

  • Minimum 3 years of industry experience, preferably in pharmaceuticals or clinical trials.

  • Field monitoring experience is preferred.


Why Join Novartis?
Novartis aims to reimagine medicine and improve lives, and this begins with our people. You will work in a collaborative, innovative, and purpose-driven environment, contributing to impactful global healthcare solutions.


Diversity & Inclusion:
Novartis is dedicated to fostering an inclusive workplace and supporting employees with disabilities. For reasonable accommodation requests during recruitment or employment, email:
diversityandincl.india@novartis.com (mention Job ID in your message).


Estimated Salary: ₹12–18 LPA (based on industry averages for CRA roles in metro cities)