Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

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)