Summary
Overview
Work History
Education
Skills
Accomplishments
Certification
Awards
Timeline
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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 -
Srishti ShettyClinical Research Professional