VISHNU VARDHAN

●Spearhead end-to-end study start-up, maintenance, and close-out activities across 10 Phase I–IV clinical trials, managing critical path milestones, regulatory timelines, and inspection-readiness expectations for 150+ patient enrollments.
●Direct site feasibility assessments, site selection, and country/site activation workflows, achieving >95% protocol adherence through rigorous investigator coordination and SOP-driven processes.
●Manage TMF/eTMF documentation lifecycle using Veeva Vault and Trial Interactive, ensuring completeness, quality, and audit-readiness per ICH-GCP and ALCOA+ standards — supporting zero critical findings during sponsor oversight visits.
●Develop investigator training materials and facilitate SIVs, IMVs, and COVs covering protocol-specific procedures, EDC workflows, and GCP compliance requirements.
●Coordinate IRB/EC submission/approval packages, Clinical Trial Insurance documentation, and regulatory submissions, maintaining HIPAA-compliant data integrity across all study workflows.
●Track vendor performance, site activity KPIs, and enrollment milestones using RealTime CTMS, Medidata Rave, Oracle InForm, and REDCap — enabling proactive risk identification and timely issue escalation.
●Manage ClinicalTrials.gov study entries/updates and DocuSign signature workflows; support IRT/IVR and eCOA/ePRO operational workflows with EDC query resolution under FDA 21 CFR Part 11-compliant systems.
●Leverage Tableau and Power BI dashboards to visualize enrollment trends, dropout rates, and site performance metrics for sponsor reporting and internal governance reviews.

• Lead site preparation for data collection across multiple oncology and medical device clinical trials, ensuring sites are fully operational and compliant with GCP, FDA, IRB, and sponsor SOPs prior to patient enrollment.
• Build and maintain strong relationships with research coordinators and site staff, providing ongoing mentorship, training, and operational support to 8-14 coordinators/data specialists across multi-site studies.
• Oversee clinical data management for multi-study programs, developing Data Management Plans (DMPs), study-specific SOPs, and work instructions to ensure ICH-GCP E6(R2)/E6(R3) and 21 CFR Part 11 compliance.
• Direct CTMS/EDC workflows including CRF design, Medidata Rave and Veeva Vault CDMS database build and validation, edit check development, query management, and database lock, ensuring accurate data capture from EMR, charts, diagnostics, and patient interviews.
• Conduct comprehensive data cleaning and quality control activities, resolving 100% of queries within sponsor timelines and achieving 100% on-time database lock for Phase II-IV trials.
• Author and submit regulatory reports including study status updates, safety reports, protocol amendments, and annual reports to IRBs and regulatory authorities, maintaining complete audit-ready documentation.
• Oversee User Acceptance Testing (UAT) for EDC systems, validating database functionality and ensuring seamless data flow across clinical operations, biostatistics, safety, and regulatory teams.
• Provide strategic oversight to CRO data-management teams, participating in vendor selection, performance review, and contract negotiations to optimize timelines, quality, and resource utilization.
• Documented data in accordance with ALCOA-C principles and study data management plans.
• Partner with site and sponsor leadership on operational planning, capacity assessments, budget adherence, and on-time milestone delivery, supporting improved revenue capture via timely data entry and clean-file readiness.
• Collaborate cross-functionally with Principal Investigators, Sub-Investigators, Clinical Operations, Biostatistics, Safety, and Regulatory teams through routine huddles and project meetings to align deliverables and ensure trial success.

• Managed site operations for a pivotal Phase III medical device trial (COMS One), supervising daily activities of coordinators and support staff while overseeing 150+ subjects with 100% data quality and prevention of unblinding.
• Prepared sites for data collection by leading site initiation visits, training research staff on protocols and EDC systems, and establishing compliant workflows for patient enrollment, data capture, and regulatory documentation.
• Built and strengthened relationships with research coordinators at investigator sites, providing mentorship, onboarding, task delegation, and performance feedback to enhance team productivity and protocol adherence.
• Implemented risk-based monitoring (RBM) and remote source data verification (SDV) strategies, increasing monitoring efficiency by 40% and reducing on-site visit requirements while maintaining 96%+ protocol adherence and 98% patient retention in 24-week studies.
• Authored regulatory reports including protocol deviations, CAPA plans, safety updates, and annual continuation applications, achieving zero critical findings across three consecutive IMVs and resolving 100% of audit findings within 48 hours.
• Coordinated expedited SAE reporting for high-morbidity populations, reducing submission times to 24 hours and enabling 100% on-time database locks across six concurrent studies.
• Facilitated daily huddles, weekly operations meetings, and monthly project reviews across multiple concurrent trials, ensuring alignment on timelines, resource allocation, and deliverable completion.
• Partnered with leadership on resource allocation, visit scheduling, and data-entry timeliness to support accurate sponsor invoicing and stable site revenue flow.
• Completed complex data collection during study visits, ensuring accurate source documentation and timely EDC entry.

• Conducted high-volume screening and enrollment for Phase I-IV cardiology trials, maintaining 97% protocol adherence across 120+ patients in eight active studies.
• Managed data cleaning activities including CRF completion, source document verification, and EDC data entry (REDCap, Veeva Vault) with zero QA findings, ensuring data accuracy, privacy, and inspection readiness.
• Prepared sites for data collection by coordinating site initiation activities, training staff on protocol requirements, and establishing compliant data capture workflows from patient screening through study close-out.
• Oversaw AE/SAE documentation and regulatory reporting, implementing a tracking system that reduced submission delays by 20% and strengthened safety compliance across multi-site trials.
• Managed and resolved data queries within sponsor timelines to maintain database quality and lock readiness.
• Delivered early-adoption training on ICH-GCP E6(R3) principles to 10+ staff through root-cause analysis sessions, improving deviation prevention and audit readiness.
• Monitored enrollment, retention, and dropout trends via custom dashboards, improving patient outreach by 22% and supporting on-time database locks and sponsor milestones.