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Clinical Research Associate

Novartis
Novartis
2+ years
Not Disclosed
10 Jan. 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

Job ID: REQ-10036180
Location: Mumbai, India
Posted on: January 14, 2025
Employment Type: Full-time, Regular


Role Summary:

As a Clinical Research Associate (CRA), you will manage site relationships to ensure sustainable trial execution. This includes performing on-site and remote monitoring activities for Phase I-IV Global Drug Development (GDD) trials while adhering to International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)/Good Clinical Practice (GCP), local regulations, and Standard Operating Procedures (SOPs).


Key Responsibilities:

  • Act as the primary liaison between Novartis and study sites, ensuring successful collaboration and deliverables.
  • Manage assigned study sites and oversee Phase I-IV protocols per Monitoring Plan and company procedures.
  • Conduct Site Initiation Visits, training site personnel on all trial-related aspects, and provide ongoing re-training as needed.
  • Perform continuous site monitoring activities (on-site and remote), ensuring compliance with protocols, regulations, and company standards.
  • Advocate for adherence to ethical and compliance standards, emphasizing human subject protection and trial result reliability.
  • Execute Site Closeout activities in accordance with SOPs and regulations, including follow-up and archiving requirements.
  • Collaborate with Site & Study Operations (SSO) Clinical Project Managers, CRA Managers, and other team members to optimize recruitment, site development, and data quality.
  • Participate in audit preparation and inspection readiness activities for site-related tasks.

Role Requirements:

  • Minimum Requirements:
    • Degree in a scientific or healthcare discipline.
    • At least 2 years of pharmaceutical industry experience or relevant field experience.
    • Experience with central/in-house or field monitoring.
    • Knowledge of international standards such as GCP/ICH, FDA, and EMA.
    • Understanding of CRA responsibilities including patient safety, data integrity, PI oversight, and compliance.

Why Novartis?

Novartis strives to reimagine medicine and improve lives, driven by a vision to become the most valued and trusted medicines company in the world. This mission is supported by a community of passionate and innovative individuals who work together to achieve breakthroughs that change lives.

What We Offer:

  • Comprehensive benefits outlined in the Novartis Life Handbook.
  • A culture of diversity and inclusion that values professional growth and collaboration.
  • Opportunities to work with and learn from driven, like-minded individuals.

Commitment to Diversity and Inclusion

Novartis is dedicated to fostering an inclusive work environment that reflects the diverse communities and patients we serve.

Accessibility:
For reasonable accommodations due to medical conditions or disabilities, contact diversityandincl.india@novartis.com with the job requisition number and your details.


Join the Novartis Network:

Not the right role? Stay connected by joining the Novartis Talent Network for updates on future opportunities.

Division: Development
Business Unit: Innovative Medicines
Functional Area: Research & Development
Location: Mumbai (Head Office)
Company/Legal Entity: Novartis Healthcare Private Limited

Ready to create a brighter future together? Apply Now