Job Title: Central CRA (Clinical Research Associate) – Registries
Location: Hyderabad, India
Job Type: Permanent | Full-Time
Travel: As required by business needs
Hiring Manager: Project Lead – ESR and Grants
About Sanofi Business Operations (SBO)
Sanofi Business Operations (SBO) is a global internal resource organization based in India, designed to centralize processes and activities across Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, Data & Digital functions. SBO acts as a strategic partner for Medical, HEVA, and Commercial organizations worldwide.
Our mission is to reduce reliance on external providers while developing deep internal expertise, leveraging India’s rich talent pool to deliver global impact.
About the Role
The Central CRA (Clinical Research Associate) serves as the primary liaison for Principal Investigators and site staff conducting rare disease registries at investigational sites. The role ensures study compliance, data quality, and effective site management throughout the study lifecycle.
Key Responsibilities
1. Feasibility & Start-up Activities
Participate in site selection with the Registries Team.
Collect and review site documents for HA/RA and IRB/EC submissions.
Prepare EC cover letters, insurance certificate applications, and track ICF customization per country/site.
Support site contracting, budget negotiation, and agreement finalization.
Upload and maintain start-up documentation in eTMF.
Ensure timely communication of study progress and updates to all stakeholders.
2. Site Monitoring
Conduct remote and onsite monitoring visits (selection, initiation, routine, close-out) per protocol, SOPs, GCP, and local regulations.
Perform remote review of study data, eCRFs, and query resolution.
Escalate issues and liaise with Data Management and vendors as needed.
3. Site Management
Track patient recruitment and enrollment status.
Ensure site facilities, resources, and staff training meet study requirements.
Build collaborative relationships with sites and vendors.
4. Safety & Quality
Ensure compliance with safety reporting requirements.
Maintain audit/inspection readiness with quality oversight and root cause analysis.
Implement corrective and preventive actions (CAPAs) as needed.
5. Study Administration & Reporting
Maintain trackers, databases, and investigator payment processes.
Ensure continuous TMF compliance from study set-up through archiving.
Contribute to study meetings, audits, inspections, and training sessions.
6. Stakeholder Management
Engage with internal/external stakeholders, investigators, and regulatory bodies.
Provide regular updates, resolve conflicts, and ensure compliance with ethical and regulatory standards.
Gather feedback to improve processes and strengthen collaboration.
Performance Indicators
Adherence to study start-up timelines and monitoring plans.
Data quality, accuracy, and timely resolution of queries.
Regulatory compliance and audit readiness.
Effectiveness in patient recruitment and retention support.
Clarity, responsiveness, and professionalism in communication.
Continuous professional development and training participation.
Timeliness and accuracy of monitoring and progress reports.
About You
Experience
3+ years in clinical research and development, including monitoring experience.
Exposure to rare diseases, observational studies, or real-world evidence preferred.
Experience working in global projects and matrix environments.
Skills
Technical: GCP, regulatory requirements (FDA, EMA), clinical trial phases, data management, medical terminology, MS Office proficiency.
Soft Skills: Strong communication, adaptability, time management, interpersonal skills, problem-solving, and ethical judgment.
Education
Degree in Pharmacy, Life Sciences, or a related scientific discipline.
Languages
High proficiency in written and spoken English.
Why Join Us?
At Sanofi, we believe progress happens when people pursue the extraordinary. You’ll have the opportunity to:
Contribute to innovative rare disease research.
Collaborate globally in a diverse and inclusive environment.
Grow through continuous learning and development opportunities.
We are committed to equal opportunities for all, regardless of race, color, ancestry, religion, gender, sexual orientation, age, disability, marital status, gender identity, or veteran status.
✨ Pursue Progress. Discover Extraordinary.
Join us in pushing boundaries, challenging convention, and making a lasting impact on global health.
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Hilo | Honolulu |Idaho :
Boise |Illinois :
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Frank Scottile Blvd |LA :
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Bangor | Brewer |Maryland :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
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Halle |Schleswig Holstein :
Kiel |Belgium :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Hungary :
Budapest |Istanbul :
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Basel | Zurich |Carlow :
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Brinny | Ringaskiddy |County Dublin :
Swords |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |Meath :
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China | Quarry Bay |Hubei :
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Sheffield |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
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Zaventem |Bosnia and Herzegovina :
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Sofia |Canada :
Canada |Ontario :
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Cairo |Estonia :
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Tallinn |Chuuk :
North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |France :
Lyon | Paris |Attica :
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Surabaya |Jakarta :
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Yavne | Be'Er Sheva | Netanya | Kfar Saba | Tel Aviv |Italy :
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Japan | Saitama |Tokyo :
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Remote Korea |Republic of Korea :
Seoul |Kuala Lumpur :
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Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
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Dubai |Hà Nội :
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