Global Clinical Operations Leader and Study Management Expert

Professional Summary

Results-driven clinical research professional with extensive experience in planning, execution, and oversight of global phase 1-4 and late-phase studies. Skilled in site management, protocol compliance, risk mitigation, and cross-functional collaboration to deliver high-quality study outcomes.

Core Competencies

Global & Regional Phases 1-4 Study Management

Operational Planning, Timelines & Risk Mitigation

Study/site Budget Development & Financial Oversight

Protocol, ICF, CRF & Monitoring Plan Development

Centralized & Risk Based Monitoring (RBM) and Issue management and Clinical Quality Risk Management (CQRM)

Site Budget & Contract Process Effectiveness

Team leadership & mentoring

Clinical systems & data management

Clinical Study Reports (Interim & Final) Review

Inspection Readiness (FDA/EMA – Zero 483 Findings)

Safety Reporting Oversight (AEs/SAEs)

Cross Functional & Program Level Collaboration

Skills

Indication: Oncology Dermatology Immunology Neurology Respiratory / Pulmonology Psychiatry Ophthalmology Orthopedics

Software: Veeva Vault (CTMS/eTMF/EDC) Medidata Rave Siebel CTMS qCTMS BizNet IWRS Power BI Imaging Platforms MS Office SharePoint RACT (RBM studies)

Professional Experience

Clinical Team Lead – Global Operations/ Fortrea Sep 2022 – Oct 2025

Provided regional/global oversight of CRAs and investigator sites to ensure compliance with study protocols, Monitoring Plans, ICH-GCP, local regulations, and study timelines.

Acted as primary liaison between CRAs and the clinical project team, conducting regular CRA calls, supporting issue escalation, and driving corrective and preventive actions (CAPA).

Led operational planning, feasibility assessments, site selection, start-up oversight, and enrollment strategy implementation for multi-site global clinical trials, including oncology studies.

Reviewed monitoring visit reports, protocol deviations, RBM signals, and site performance metrics to ensure quality, compliance, and proactive risk mitigation.

Developed and delivered study-specific training materials, monitoring tools, and presentations for CRAs and sites; mentored cross-regional CRAs through assessment visits and performance coaching.

Oversaw centralized and risk-based monitoring strategies including SDV planning, risk indicator definition, trigger management, and site-level analytics.

Ensured inspection readiness through oversight of eTMF completeness, quality trending, and support during FDA/EMA inspections with zero critical findings.

Collaborated with Data Management, TMF Operations, vendors, and cross-functional teams to ensure timely and high-quality project deliverables.

Contributed to financial oversight including budget tracking, site payments, revenue forecasting, and change order assessments.

Key Achievements:

- Designed and implemented Power BI dashboards for centralized oversight of compliance, monitoring quality, and operational risk. - Served as SME for Veeva Vault eTMF, training cross functional teams and improving document quality and inspection readiness.

Sr. CRA-SRS / Centralized Oversight/ IQVIA Aug 2020 – Sep 2022

Lead the review and oversight of site visit reports (SVRs) and study documentation, ensuring compliance with protocols, SOPs, GCP guidelines, and project timelines to maintain high-quality data and reporting standards.

Identify, track, and escalate site- and CRA-related findings, trends, and risk factors to project teams, supporting proactive risk mitigation and quality management across studies.

Provide coaching, mentoring, and guidance to CRAs and junior staff, enhancing operational efficiency, report accuracy, and adherence to study requirements. Collaborate with project teams to analyze data trends, support corrective and preventive action plans, and contribute to process and quality improvements for global and regional late-phase studies.

Sr. Clinical Research Associate/Accutest Research Laboratories Jun 2017 – Aug 2020

Support site selection, initiation, monitoring (onsite or remote), and close-out visits in accordance with study-specific Monitoring Plans, ensuring compliance with protocols, GCP, and regulatory requirements.

Manage all aspects of site operations, including subject recruitment plans, informed consent, data integrity, audit readiness, and resource optimization.

Prepare accurate and timely trip reports, track project progress, and escalate issues or risks to achieve study objectives. Tracked subject status and enrolment metrics using CTMS reports.

Assist in protocol development, CRF design, clinical trial reports, IP management (storage, dispensing, reconciliation, accountability), and coordination with investigators, vendors, and regulatory authorities.

Monitor and follow up on Serious Adverse Events (SAEs), including reporting, narratives, and data queries, ensuring adherence to established guidelines.

Achievement: Managed 8–10 sites simultaneously, ensuring on-time recruitment and protocol adherence. Conducted 150+ site visits (initiation, monitoring, close-out), maintaining audit-ready documentation with minimal findings. Trained and mentored site staff, improving protocol compliance and reducing query rates by 15–20%.

Earlier Roles

Clinical Research Associate, Lambda Therapeutics Research PVT LTD Nov 2015- Jul 2017

Clinical Trial Assistant (CTA) – Lambda Therapeutics Research PVT LTD Jun 2014- Oct 2015

Education

Master of Pharmacy (Pharmacology) – L.M. College of Pharmacy, India

Bachelor of Pharmacy – Arihant School of Pharmacy, India

Certificate and Awards

People Excellence Award & Grade 1 Performance Award – Fortrea at multiple times. Best CRA of the Year – Accutest Research Lab and Lambda therapeutics LTD

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