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Central Cra (Clinical Research Associate)- Registries

3+ years
Not Disclosed
10 June 6, 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

 

Central CRA (Clinical Research Associate) – Registries | Hyderabad | Sanofi

Job Summary

Sanofi is hiring a Central Clinical Research Associate (CRA) in Hyderabad, India, for its Registries Division focusing on rare diseases. In this full-time, permanent, on-site role, you'll contribute to site monitoring, data validation, and regulatory compliance across global clinical registries. This is your chance to work at the intersection of healthcare innovation, digital transformation, and real-world evidence, playing a key role in improving access to life-changing treatments.


Key Responsibilities

  • Act as liaison for site teams and investigators for registry studies

  • Conduct feasibility and study start-up tasks: IRB/EC submissions, ICF review, budget negotiation

  • Monitor trial sites remotely and on-site for protocol, GCP, and regulatory compliance

  • Ensure timely data collection, quality checks, and issue resolution (eCRF, SDV, TMF)

  • Collaborate with global teams and vendors for clinical trial execution

  • Ensure safety reporting and inspection-readiness across assigned sites

  • Support training, CAPA implementation, and continuous process improvements


Required Skills & Qualifications

  • 3+ years of experience in clinical research and monitoring

  • Experience in rare diseases, registries, or real-world evidence (RWE) is a plus

  • Strong understanding of ICH-GCP, GVP, local regulations, and clinical SOPs

  • Proficiency in eCRF, eTMF, and other PV/clinical trial management systems

  • Strong stakeholder communication and remote monitoring skills

  • Familiar with MedDRA, safety reporting, and regulatory documentation workflows

  • Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or Clinical Research


Perks & Benefits

  • Competitive salary (Not disclosed; industry-aligned for Hyderabad CRA roles)

  • Exposure to global rare disease registries and real-world studies

  • Professional development and international collaboration

  • Inclusive workplace with focus on digital tools and AI in healthcare

  • Opportunity to contribute to chronic disease innovation


Company Description

Sanofi is a global biopharmaceutical leader accelerating breakthroughs in immunology, rare diseases, vaccines, and chronic care. Through our Sanofi Business Operations in India, we aim to centralize excellence and build strong capabilities in clinical development and real-world research.


Work Mode

On-site – Hyderabad, India
(Travel required as per business needs)


Call-to-Action

If you're a motivated CRA with a passion for data quality, patient safety, and real-world clinical evidence, apply now and shape the future of healthcare with Sanofi.