Job Description: Central CRA
Location: India
Company: Sanofi Business Operations (SBO)
About Sanofi Business Operations (SBO)
Sanofi Business Operations (SBO) is an internal organization within Sanofi, based in India, created to centralize processes and activities across Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, and Data & Digital functions.
Our mission is to reduce reliance on external service providers, build internal expertise, and leverage an exceptional talent pool to deliver strategic and tactical support to Medical, HEVA, and Commercial organizations globally.
Position Summary
The Central Clinical Research Associate (CRA) serves as the primary liaison for Principal Investigators (PIs) and site staff involved in rare disease registries. This role ensures compliance with protocols, Good Clinical Practice (GCP), regulatory requirements, and company SOPs, while maintaining high-quality site and study management throughout the clinical trial lifecycle.
Key Responsibilities
1. Feasibility & Study Start-up
Participate in site selection with the Registries Team.
Collect and review site documents for submission to Health Authorities (HA), Regulatory Authorities (RA), Ethics Committees (EC), or Institutional Review Boards (IRB).
Prepare EC cover letters and additional submission materials.
Manage EC/IRB queries and site communications.
Coordinate site contracts, budget negotiations, and final agreements.
Customize and review informed consent forms (ICF) per local requirements.
Upload and maintain start-up documents in the eTMF.
Ensure stakeholders are informed on project progress, updates, and issues.
2. Site Monitoring & Data Management
Conduct remote and onsite monitoring visits (site selection, initiation, routine, and close-out).
Review data sources, verify case report forms (eCRF), and ensure timely query resolution.
Coordinate with Data Management teams and support international data collection projects.
Ensure patient recruitment follow-up, enrolment status tracking, and site staff/system training.
Collaborate with vendors for monitoring and start-up activities.
3. Safety & Quality Assurance
Ensure accurate and timely safety reporting at sites.
Maintain audit/inspection readiness, identify root causes of issues, and implement CAPAs.
Perform quality control checks for site-level study conduct.
4. Study Administration
Maintain trackers, tables, and databases to monitor study progress.
Ensure TMF/eTMF compliance from study start-up to archiving.
Participate in investigator meetings, operational meetings, audits, inspections, and trainings.
Support investigator payment processes (where applicable).
5. People, Performance & Stakeholder Engagement
Align with internal/external stakeholders and Principal Investigators on registry activities.
Recommend and implement process improvements.
Ensure monitoring quality, data accuracy, regulatory compliance, and patient retention.
Maintain effective communication with site staff, vendors, sponsors, and regulatory bodies.
Build collaborative relationships and resolve stakeholder conflicts while ensuring compliance and ethics.
Actively participate in professional development and training.
About You
Experience
Minimum 3+ years in clinical research & development, including clinical trial monitoring.
Experience in rare diseases, observational studies, or real-world evidence preferred.
Strong skills in data verification, issue resolution, and project management.
Experience in global projects and international matrix environments.
Skills
Technical Skills
Knowledge of GCP and regulatory requirements (FDA, EMA, etc.).
Familiarity with clinical trial processes, phases, and methodologies.
Proficiency in data management, reporting, and medical terminology.
Competence in Microsoft Office and relevant clinical tools.
Soft Skills
Strong communication (written and verbal).
Attention to detail and problem-solving ability.
Adaptability to changing requirements and environments.
Effective time management and prioritization.
Strong interpersonal skills and ethical judgment.
Education
Degree in Pharmacy, Life Sciences, or a related scientific discipline.
Languages
High proficiency in written and spoken English.
Why Join Sanofi?
At Sanofi, we believe in pursuing progress and discovering extraordinary outcomes. We invest in your growth, encourage innovation, and empower you to challenge convention while working on transformative science.
We are committed to building an inclusive workplace and provide equal opportunities regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, or protected veteran status.
📽 Watch our ALL IN video and learn more about our Diversity, Equity, and Inclusion actions at sanofi.com.
Pursue Progress. Discover Extraordinary.
Join us in shaping a healthier future—where your career growth is just as transformative as the work we do together.
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