Shivani Shetty
R&D Clinical trial support associate| Clinical Research| Sanofi
- Role
- R & d Clinical Trial Support Associate at Sanofi
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Shivani Shetty
I’m a passionate and detail-oriented clinical research professional with experience in both centralized monitoring and site coordination. Currently, I work as a Centralized Monitor at IQVIA, where I support global clinical trials by ensuring data accuracy, protocol compliance, and patient safety — all through a remote, risk-based monitoring model.My career began as a Clinical Research Coordinator, giving me hands-on experience with patient enrollment, informed consent, regulatory documentation, and site management. This foundation helped me build a strong understanding of the clinical trial process from the ground up, which I now apply to centralized monitoring. Centralized Monitoring (IQVIA)• Monitoring 50+ clinical trial sites remotely in RBQM model • Identifying and mitigating site-level risks with targeted action plans• Collaborating with CRAs and study teams to ensure protocol adherence• Conducting trend analysis and data reviews to resolve discrepancies• Managing eTMF and ICF documentation for audit readiness• Supporting continuous improvement through team discussions and escalations Clinical Research Coordination (CLINISYD Research Global)• Managed full-site operations across 10 protocols, from initiation to close-out• Coordinated patient recruitment, informed consent, and medical history screening• Maintained audit-ready trial documentation and regulatory submissions• Handled investigational products and biological samples (PK/ADA)• Reported AEs/SAEs, protocol deviations, and safety updates to ECs• Supported SIVs, SMVs, and collaborated with cross-functional teamsI enjoy learning, collaborating, and contributing to meaningful work that makes a difference.
Experience
R & d Clinical Trial Support Associate
Feb 2026 — Present · Hyderabad, IN
Education
Rajiv Gandhi University of Health Sciences | Shree Devi Collage of Pharmacy
Bachelor of Pharmacy - BPharm, Pharmacy
2017 — 2021
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