Vaishnavi Muthukumar

Results-driven global clinical trial professional with 10+ years of healthcare experience and 7+ years managing Phase I–III Clinical trials both FSP and full-service global programs across North America, Europe, APAC, LATAM, and Africa. At IQVIA, functioned at full Clinical Study/Project Manager scope — owning end-to-end study operational strategy, country-level and site-level planning, CRO and vendor oversight, budget and spend management, inspection-ready TMF governance, CTMS management, monitoring plan review, protocol deviation tracking, and executive-level governance reporting. Specialized expertise in ophthalmology imaging (OCT, FA, SD-OCT, BCVA), reading center management, and BICR/RECIST 1.1 operations.

Adept in GCP, ICH guidelines, and 21 CFR Part 11 compliance. Seeking a fully remote Global Clinical Trial Manager or Clinical Study Manager role.

Associate Project Manager (Full Clinical Study Manager Scope) - IQVIA - United States | Remote

(2021-09)

Own end-to-end operational delivery for global Phase II and III Oncology, Ophthalmology, Dermatology, Hematology, Cardiology, and Internal Medicine trials across 5 regions. Manage 9 global start-ups and 4 transitioned studies, supporting enrollments up to 1,000 patients per study — functioning at Clinical Study/Project Manager level.

• Lead operational strategy, planning, and execution for assigned studies; develop and maintain country-level and study-level plans covering timelines, budget, risk, quality, and recruitment milestones — directly aligned with Global Study Manager directives.
• Serve as primary escalation point for site activation issues, protocol deviations, and vendor performance; identify risks and implement mitigation strategies to protect study deliverables and sponsor commitments.
• Oversee CRO partners and external vendors (translation, material distribution, specialty services) against contractual timelines; resolve performance issues and coordinate vendor deliverables for on-time study execution.
• Manage study budgets including PO creation, invoice reconciliation, spend tracking, and external cost forecasting in collaboration with finance and leadership; contribute to scope change assessments and change order development.
• Ensure CTMS and eTMF remain accurate, complete, and inspection-ready through periodic quality reviews, gap resolution, and audit trail oversight; lead protocol deviation documentation and regulatory alignment.
• Review and approve monitoring plans and study-level operational plans; partner with Data Management to ensure alignment on database timelines and data delivery; support internal audits and regulatory inspections.
• Develop and maintain study tracking tools, KPI dashboards, and reporting; deliver monthly client governance and executive-level updates; facilitate cross-functional team meetings and drive action item accountability.
• Managed imaging vendors and central reading centers for ophthalmology trials, overseeing vendor selection, contract execution, performance tracking, and data delivery timelines; ensured reading center compliance with imaging protocols and quality standards.
• Oversaw ophthalmologic assessment workflows including OCT (Optical Coherence Tomography), FA (Fluorescein Angiography), SD-OCT, and BCVA (Best Corrected Visual Acuity) across global sites; coordinated site training, equipment qualification, and image submission compliance to meet study protocols.
• Directed biomarker sample collection and management programs within ophthalmology and oncology trials — including kit supply management, cold-chain logistics oversight, central lab coordination, and sample tracking to ensure protocol-compliant and audit-ready operations.
• Completed IQVIA Biotech PM Development Program: scope, financial, risk, vendor, quality, and communication management — including SOP development and process optimization.

Assistant Project Manager - Bioclinica - United States | Imaging & Operations CRO

(2019-04 - 2021-09)

Managed imaging and operational components of 10+ global Phase II–III oncology trials (120–1,000 patients), covering full start-up through close-out lifecycle.

• Developed and maintained project timelines, RAID logs, and project charters; led investigator meeting preparation and virtual and on-site site training sessions across global sites.
• Partnered with CTMs, CRAs, Medical Monitors, and cross-functional stakeholders to ensure milestone adherence; reviewed imaging protocol requirements and resolved site-level operational issues including activation escalations.
• Oversaw imaging vendor operations including reading center performance monitoring, imaging data quality reviews, site equipment qualification tracking, and resolution of imaging non-conformances across multi-regional trials.
• Developed and maintained Image Review Charters and Data Transmittal Forms (DTFs) for oncology imaging trials; defined imaging requirements, data submission standards, and reading center workflows in alignment with sponsor protocols and regulatory expectations.
• Performed QC review of images received from global sites against RECIST 1.1 criteria; assessed image quality, completeness, and protocol compliance prior to reader assignment, ensuring only audit-ready submissions advanced through the review workflow.
• Supported Blinded Independent Central Review (BICR) operations, oncology endpoint adjudication, coordinating the two-independent-reader workflow, managing adjudication cases where reader assessments diverged, and ensuring final RECIST 1.1 reads were locked and audit-ready for BLA/NDA submission support.
• Contributed to SOP development, process improvement initiatives, and ICH-GCP/sponsor-specific compliance across all assigned programs.

Drug Safety Associate - Sanofi-Aventis

(2018-01 - 2018-10)

• Processed and assessed SAEs and non-serious AEs for clinical and post-marketing products; contributed to PSUR/PBRER aggregate reporting and SAE database reconciliation. Utilized ARGUS, AWARE, and Siebel.

Drug Safety Coordinator - Sollers

(2016-06 - 2017-12)

• Evaluated and processed ICSRs for investigational and marketed products; conducted signal detection (Empirica); contributed to aggregate safety reporting and database quality checks.

Bachelor of Dental Surgery (BDS) - Health Sciences - Sri Ramachandra Medical University, India

Certificate Program - Safety and Pharmacovigilance - Safety and Pharmacovigilance Program

Biotech Project Manager Development Program - Project Management - IQVIA