Sanofi is Hiring for Clinical Research Associate

Sanofi, a global pharmaceutical leader, is hiring a Central Clinical Research Associate (CRA) – Registries for our Sanofi Business Operations (SBO) team in Hyderabad, India. With a mission to pursue progress and discover extraordinary medicines, Sanofi supports Specialty Care, Vaccines, and R&D functions globally. Join our inclusive team to drive impactful clinical research in rare disease registries!

Job Details

• Job ID: R-218809
• Category: Regulatory
• Location: Hyderabad, Telangana, India
• Work Type: Permanent, Full-time
• Travel: As per business need
• Work Model: On-Site
• Apply: Sanofi Careers

Job Role: Central CRA (Registries)

The Central CRA serves as the primary liaison for Principal Investigators and site staff in rare disease registries, ensuring compliance with ICH-GCP guidelines, local regulations, and Sanofi SOPs. Below are the role details:

Qualifications

• Education: Degree in Pharmacy, Life Sciences, or related discipline
• Experience: 3+ years in clinical research and trial monitoring (rare disease or real-world evidence experience preferred)
• Languages: High proficiency in written and spoken English

Required Skills:

• Strong knowledge of Good Clinical Practice (GCP) and regulatory requirements (FDA, EMA).
• Proficiency in clinical trial processes, data management, and medical terminology.
• Expertise in Microsoft Office (Word, Excel, PowerPoint).
• Excellent communication, time management, and interpersonal skills.
• Strong attention to detail and ethical judgment.

Preferred Skills:

• Experience in global projects and matrix environments.
• Familiarity with eTMF, eCRF, and data quality control processes.

Key Responsibilities

• Feasibility Activities: Support site selection for registries with the Registries Team.
• Study Start-Up:
  • Collect and review site documents for Health Authority (HA)/Ethics Committee (EC) submissions.
  • Prepare EC cover letters, customize Informed Consent Forms (ICFs), and ensure regulatory compliance.
  • Assist in site contract processes, budget negotiations, and eTMF documentation.
• Site Monitoring (On-Site & Remote):
  • Conduct Site Selection, Initiation, Routine Monitoring, and Close-Out Visits per protocol and GCP.
  • Review eCRF data, resolve queries, and ensure data quality and integrity.
  • Manage patient recruitment and retention, ensuring adequate site facilities and staff training.
• Safety & Quality:
  • Ensure robust safety reporting and audit/inspection readiness.
  • Perform root cause analysis and implement CAPA for deviations.
• Study Administration:
  • Maintain trackers, databases, and eTMF for study progress.
  • Participate in investigator payment processes and study meetings.
• Stakeholder Management:
  • Build relationships with investigators, vendors, and regulatory bodies.
  • Communicate study progress, resolve conflicts, and ensure compliance.
  • Gather stakeholder feedback to improve processes.

Performance Metrics

• Adherence to study start-up timelines and monitoring visit frequency.
• High data quality with minimal discrepancies and timely query resolution.
• Effective patient recruitment and retention support.
• Clear, timely, and accurate reporting (monitoring visit reports, progress reports).

Why Join Sanofi?

Sanofi’s Hyderabad-based SBO team, rated 4.0/5 on Glassdoor for innovation, supports global clinical operations with a focus on internal expertise. Here’s why you should join us:

• Innovative Environment: Work on rare disease registries with cutting-edge methodologies.
• Career Growth: Access extensive training and global project exposure.
• Global Impact: Contribute to medicines improving lives in 100+ countries.
• Inclusive Culture: Thrive in a diverse, equitable workplace with a 4.2/5 rating for culture on AmbitionBox.

How to Apply

To apply, submit the following via Sanofi Careers by July 31, 2025:

• Updated resume highlighting clinical research and monitoring experience.
• Copies of educational certificates (Pharmacy/Life Sciences degree).
• Aadhar Card, PAN Card, and relevant certifications (e.g., GCP training).
• Cover letter detailing your fit for the Central CRA role.

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Note: Candidates may need to attend in-person or video interviews and present state/government-issued ID.

About Sanofi

Sanofi, headquartered in Paris, is a global healthcare leader with over 100,000 employees, driving innovation in Specialty Care, Vaccines, and R&D. Our Hyderabad SBO hub centralizes processes to support global clinical operations, emphasizing quality and efficiency. Learn more at www.sanofi.com.

Equal Opportunity Statement

Sanofi is an Equal Opportunity employer, considering candidates regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or age. We provide reasonable accommodations for individuals with disabilities. Contact careers@sanofi.com for support.

Join Sanofi to pursue progress and discover extraordinary in clinical research. Apply now and make a difference from Hyderabad!