Sai Siddharth M.
Clinical Operations | Expertise in Global Clinical Trial operations from Startup to Close out, eTMF Management & Regulatory Submissions | Vendor oversight | Clinical systems- eTMF, CTMS, EDC
- Role
- Clinical Study Associate at Tata Consultancy Services
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Sai Siddharth M.
As a dedicated Clinical Study Associate, I specialize in managing end-to-end clinical trial operations, from study start-up to close-out. With hands-on experience across multiple global clinical trials, I ensure seamless execution and compliance with ICH-GCP guidelines, regulatory standards, and organizational SOPs.My expertise spans: • Study documentation management, including TMF setup, maintenance, and audit readiness. • Efficient use of clinical systems like eTMF, CTMS, IxRS, SIP, eCRF, etc. for streamlined processes. • Regulatory submissions, stakeholder coordination, and milestone tracking. • Delivering high-quality trial outcomes while ensuring compliance and efficiency.I am passionate about optimizing clinical operations and supporting groundbreaking research that improves patient outcomes. Let’s connect to collaborate or share insights about advancing clinical trials globally!
Experience
Clinical Study Associate
Dec 2022 — Present · Mumbai, IN
Led execution of clinical operations strategies including study start up to close-out per ICH GCP E6 guidelines.• Managed eTMF, and CTMS, ensuring regulatory compliance and inspection readiness.• Collaborated with global teams to facilitate submissions for health authorities.• Supported audit preparation, responses, and corrective actions for inspection readiness.• Oversaw informed consent process, template preparation, and country/site-specific approvals.• Developed and implemented project management tools for decision-making (Decision-Issues-Action log) and risk management (risk management plan)• Fostered strong client relationships through direct interactions, ensuring clear communication and alignment of project goals and expectations.• Collaborated closely with cross-functional teams to ensure seamless execution of clinical trials and adherence to project timelines and qualitystandards.
Education
JSS College of Pharmacy - India
Master's degree, Pharmacy Practice
2020 — 2022
JSS College of Pharmacy - India
Postgraduate Diploma, Clinical Research
T.V.M. College of Pharmacy
Bachelor of Pharmacy, Pharmacy
2016 — 2020
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