Srishti Shetty
Clinical Research Professional
Mumbai
Summary
Clinical Research Professional with 4 years of global experience in Phase II/III trials across Ophthalmology, Oncology, Cardiology, and Gastroenterology. Proven track record in centralized monitoring, digital clinical systems (CTMS, Medidata, Veeva Vault, Spotfire), and project coordination across cross-functional stakeholders. Experienced in protocol compliance, risk-based monitoring, TMF oversight, and vendor management. Passionate about leveraging eCOA and Digital Patient Solutions (DPS) to improve patient-centric outcomes and enhance clinical trial efficiency. Holds a Bachelor's in Pharmacy and an MBA in Project Management. Currently preparing for the CAPM project management exam by October 2025 to further strengthen project leadership capabilities.
Overview
4
4
years of professional experience
5
5
Certifications
Work History
Central Monitor I
Syneos Health India Private Limited
Remote
05.2024 - Current
- Reviewed protocols and identified key safety/data integrity risks for centralized monitoring strategies.
- Performed MVR reviews to ensure compliance with GCP and internal SOPs.
- Perform site risk assessments and escalate significant protocol violations and data issues to CRAs and study teams.
- Led issue escalation processes and CAPA documentation for protocol deviations.
- Supported digital systems review including CTMS, Almac, Spotfire, Cluepoints and Veeva Vault.
- Monitored and tracked key performance indicators (KPIs), contributing to overall study timelines.
- Provided cross-functional status updates in project team calls.
- Coordinated with clinical ops and safety teams for risk mitigation and action resolution.
- Served as monitoring oversight for an ophthalmology study and backup support for a cardiology medical device study.
- Participated in study startup by managing document uploads and access management.
Centralized Study Associate
Fortrea Inc.
Bengaluru
03.2023 - 05.2024
- Generated centralized study risk profile reports and facilitated real-time issue escalation.
- Create study reports using Power BI dashboards for study oversight and stakeholder updates.
- Supported CRAs by reviewing monitoring visit outputs and performance trends.
- Provide periodic risk profile reports as described in central monitoring plan to site and remote monitors for all investigational sites.
- Managed study-specific documentation within Veeva TMF, CTMS, and Medidata systems.
- Liaised with vendors and sites to coordinate data access and system readiness.
- Assist in Investigator Payment processing.
- Ad hoc task- Assisting in extracting reports from Clinical data systems for weekly updating of Power BI analytical dashboard process manually.
Centralized Monitoring Assistant
IQVIA
Mumbai
06.2021 - 03.2023
- Assisted in document management, system reports, and project execution support.
- Conducted QC reviews, maintained study trackers, and uploaded data to eTMF systems.
- Supported SRtE Spotfire toolkit and blinded/unblinded monitoring tasks.
- Collaborated with CRAs and vendors to ensure site compliance and data accuracy.
- QC review of Investigator Payments.
- Coordinating activities with study sites and ensuring adherence to study protocols and regulatory guidelines.
- Managing and organizing study-related documentation, such as informed consent forms and case report forms.
- Tracking and maintaining study data, ensuring accuracy and completeness.
- Facilitating communication among various stakeholders, including investigators, sponsors, and study participants.
- Organizing study meetings and ensuring timely communication of updates and progress.
- Overseeing study supply management and distribution.
- Helping with data analysis and generating reports for the study team.
- Ensuring compliance with all applicable regulations and guidelines throughout the study.
Education
MBA - Project Management
Dr DY PATIL INSTITUTE OF ONLINE LEARNING
Pimpri-Chinchwad, India 04.2001 -
Bachelors of Pharmacy -
PARUL INSTITUTE OF PHARMACY
Vadodara, India 04.2001 -
Skills
- Digital Patient Solutions (DPS)
eCOA / eConsent systems
Clinical System Lifecycle Management
Risk & Issue Escalation
Project Coordination
Cross-functional Collaboration
Stakeholder Engagement
Vendor Oversight
TMF Management
Centralized Monitoring
KPI Reporting
Veeva Vault,
CTMS Medidata Power BI Spotfire, Cluepoints
ICH-GCP Compliance
Accomplishments
- Enabled delivery of a global ophthalmology trial as unblinded central monitor, ensuring adherence to protocol timelines and safety standards.
- Collaborated with cross-functional stakeholders and vendors to streamline data workflows using Medidata and Spotfire.
- Supported central monitoring and risk-based oversight across multiple studies, reducing resolution turnaround for data issues by 20%.
Certification
GCP for Medical Devices – Syneos Health, 2024
Awards
- Sponsor Appreciation - Opthalmology study at Syneos Health for streamline data and completing data review backlogs
- Spotlight Award- At Syneos Health for teamwork and customer satisfaction
- Project Excellence Award- At Syneos Health for ensuring timely and high-quality delivery of work by thoroughly understanding customer requirements and aligning my efforts to meet or exceed their expectations.
Timeline
GCP for Medical Devices – Syneos Health, 2024
09-2024
GCP Training and Exam – Syneos Health, 2024
09-2024
Central Monitor I
Syneos Health India Private Limited
05.2024 - Current
Project Management course: Beginner to project manager
01-2024
Centralized Study Associate
Fortrea Inc.
03.2023 - 05.2024
Centralized Monitoring Assistant
IQVIA
06.2021 - 03.2023
Advanced PG Diploma in Clinical Research Management
02-2021
Excel for Healthcare Professionals
01-2021
MBA - Project Management
Dr DY PATIL INSTITUTE OF ONLINE LEARNING
04.2001 -
Bachelors of Pharmacy -
PARUL INSTITUTE OF PHARMACY
04.2001 -
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