Sai Siddharth M
Clinical Operations Specialist | Product Development - Global Clinical Operations
Mumbai,Maharashtra
Summary
Seeking roles in Clinical Trial Management, TMF/eTMF Specialization, Regulatory Affairs, or Clinical Research/Operations where I can apply my multi-domain expertise, system knowledge, and documentation skills to contribute to quality trial execution and regulatory compliance.
Clinical research professional with 4+ years of cross-functional experience in clinical operations, trial coordination, TMF management, and regulatory compliance. Proven track record in managing global studies from start-up through close-out, maintaining high-quality documentation, supporting system integration, and ensuring inspection readiness. Versatile, detail-oriented, and adept in handling CTMS/eTMF systems, vendor communication, site coordination, and clinical data processes. Open to opportunities in Clinical Trial Management, TMF/eTMF, Regulatory Affairs, and broader Clinical Operations.
Overview
4
4
years of professional experience
7
7
years of post-secondary education
Work History
Clinical Study Associate
Tata Consultancy Services
Mumbai
12.2022 - Current
- Supported global clinical trials from start-up through close-out, ensuring timely tracking of milestones such as FPFV, LPLV, DBL, CSR, and SOA updates.
- Managed CTMS entries for protocol amendments, country/site details, and investigational product (IMP) updates.
- Tracked and managed clinical supply shipments, expiry logs, and batch numbers in alignment with study timelines.
- Oversaw eTMF documentation using Veeva Vault; ensured audit readiness by resolving gaps, aligning metadata, and validating document versioning and completeness.
- Collaborated with study teams to upload and reconcile essential documents throughout trial lifecycle.
- Managed vendor onboarding, system access requests, and medical emergency contacts.
- Coordinated with sites and vendors for biomarker and PK sample kit shipments, reconciliations, and logistics.
- Maintained essential study trackers including enrollment logs, site/vendor contact lists, and drug shipment logs and liaised with CROs and third-party vendors for document follow-ups and milestone confirmations.
- Led efforts in TMF final QC, RAVE CD shipment tracking, and final document reconciliation.
- Assisted in preparing CSR appendices by compiling essential documents and ensuring version control.
- Contributed to global study audits by preparing study documentation, resolving TMF queries, and ensuring alignment with SOPs and regulatory standards.
Clinical Research Associate
Ethix Pharma
Bengaluru
06.2022 - 11.2022
- Conducted site initiation, routine monitoring, and close-out visits across Phase II-III studies.
- Verified source data and ensured CRF accuracy and query resolution within sponsor timelines.
- Managed SAE and ADR documentation and reporting per protocol and local requirements.
- Ensured sites maintained accurate and complete regulatory and subject documentation.
- Acted as a liaison between sponsor and sites to ensure timely completion of study activities.
- Assisted with regulatory submissions and responses during monitoring visits.
Clinical Research Coordinator
JSS Medical College and Hospital
Mysuru
06.2021 - 05.2022
- Assisted Principal Investigator in screening and enrolling eligible participants in accordance with ICH-GCP guidelines.
- Conducted informed consent processes, maintained Trial Participant logs, and supported compliance with protocol timelines.
- Maintained ISF, prepared site for audits, and submitted reports to the Ethics Committee.
- Documented and reported SAEs/SADEs in accordance with site SOPs and sponsor timelines.
- Coordinated monitoring visits and resolved findings related to data accuracy and documentation.
- Maintained CRFs, query resolution logs, and study-specific trackers.
Education
PG Diploma - Clinical Research
JSS College of Pharmacy
05.2021 - 05.2022
M. Pharm - Pharmacy Practice
JSS College of Pharmacy
Mysuru 2020 - 2022
B. Pharm - Pharmacy
TVM College of Pharmacy
Aug.2016 - Aug.2020
Skills
- Veeva Vault
- Oracle Siebel CTMS
- D2eTMF
- Medidata RAVE
- PDMS
- SIP
- Microsoft Office
- Excel
- PowerPoint
- Outlook
- SharePoint
- Trackers
- ICH-GCP
- TMF Reference Model
- 21 CFR Part 11
- ALCOA
Websites
Certification
- Project Management: Health Care Projects, LinkedIn
- Training in Risk-based Monitoring and Project Management, TCS
- GCP for Clinical Trials with Human Subjects, NIDA/NIH
Key Achievements Projects
- Improved eTMF completeness by streamlining cross-functional document workflows for 3 global studies.
- Reduced vendor response turnaround by 20% through proactive SOA tracking and escalation.
- Played a key role in achieving 100% audit readiness for two major global clinical trials.
Career Focus
Seeking roles in Clinical Trial Management, TMF/eTMF Specialization, Regulatory Affairs, or Clinical Research/Operations where I can apply my multi-domain expertise, system knowledge, and documentation skills to contribute to quality trial execution and regulatory compliance. My expertise includes providing comprehensive operational support to study leads, managing key clinical trial tools and trackers, overseeing investigational medicinal product logistics, ensuring TMF completeness and inspection ready. I am particularly motivated by the roles that emphasize inspection readiness, process optimization, vendor and site coordination throughout the study lifecycle.
Timeline
Clinical Study Associate
Tata Consultancy Services
12.2022 - Current
Clinical Research Associate
Ethix Pharma
06.2022 - 11.2022
Clinical Research Coordinator
JSS Medical College and Hospital
06.2021 - 05.2022
PG Diploma - Clinical Research
JSS College of Pharmacy
05.2021 - 05.2022
M. Pharm - Pharmacy Practice
JSS College of Pharmacy
2020 - 2022
B. Pharm - Pharmacy
TVM College of Pharmacy
Aug.2016 - Aug.2020
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