Centralized Monitoring Lead - IQVIA - Bangalore, India
(2023-02)
- Lead centralized monitoring team for global Phase II–III studies across start-up to close-out, managing and mentoring project teams to ensure Risk-Based Monitoring (RBM) oversight
- Develop and implement Risk Assessment and Mitigation Plans (RAMPs), Key Risk Indicators (KRIs), thresholds, and triggers
- Review and analyze data trends across sites and regions, driving risk mitigation strategies and ensuring timely execution of corrective and preventive actions
- Perform centralized data review to identify risks and protocol deviations, and compliance issues
- Manage EAC/Budget forecasting, variance analysis, and investigator payments from start-up to close out of the study
- Drive TMF quality, metrics, and inspection readiness
- Oversee key clinical metrics including monitoring visits/reports, action items, open queries, and missing pages
- Provide support for data cleaning oversight, data reconciliation, query management and conduct lock readiness meetings with cross functional teams
- Manage investigational product (IP) for assigned studies, identifying risks and implementing mitigation strategies including re-supply, re-labeling, and import/export license compliance
- Manage vendor system access requests by reviewing, validating, and approving in compliance with SOPs and regulatory requirements for various platforms including EDC, IXRS, Medable, WCG, Investigator Portal, and Q2L
- Support audits with proactive issue resolution and compliance oversight
- Leading Departmental initiatives to enhance processes and operational efficiency
Site Report Specialist - IQVIA - Bangalore, India
(2024-02)
- Review Site Visit Reports (SVRs) for assigned studies to ensure compliance with protocol, SOPs, GCP guidelines, and timelines
- Provide guidance to Clinical Project Managers (CPMs) on developing visit report annotations and guidelines; support CRAs for efficient report completion
Centralized Study Specialist I - LabCorp Drug Development - Bangalore, India
(2021-08 - 2023-01)
- Managed a team of four who are responsible for sharing preparatory pack reports with the CRAs
- Supported centralized monitoring and remote oversight for global trials
- Conducted SDV backlog and site risk analyses
- Prepared sponsor-facing study status reports
- Performed monthly QC of preparatory packs and analyzed site/study-level data using statistical methods for identifying trends and risks
Senior Central Monitor - IQVIA - Bangalore, India
(2018-05 - 2021-08)
- Conducted centralized review of site data, KRIs, and historical performance per Central Monitoring Plan; prepared I-Site Packs, remote monitoring summaries, and biweekly KRI analysis reports
- Collaborated with sponsor teams to provide input on project-specific Central Monitoring Plans; monitor data trends and perform compliance checks through regular quality reviews
- Contributed to development and enhancement of study-specific tools, identified improvement areas, and shared advancement ideas; highlight study issues and country-level trends during client and stakeholder calls
- Participated in study team and client meetings for project updates, train and mentor new hires on clinical research fundamentals and process workflows
Senior Clinical Process Associate - IQVIA - Bangalore, India
(2016-01 - 2018-04)
- Supported Lead clinical Analyst and Clinical Lead for all the required activities
- Preparation of Minutes of the Meeting (MOM) for all weekly team meetings
- Supported eTMF review, visit tracking, and investigator payment reconciliation
- Tracked investigators alert/ safety letters in CTMS and follow up with CRAs for reconciliation of essential documents
Vendor access management team lead - IQVIA - Bangalore, India
(2017-03 - 2018-04)
- Led and manage a team of Vendor access management Team and CAPA activities
Clinical Research Coordinator - Shri Krishna Hrudayalaya & Critical Care Centre - Dhantoli, Nagpur, India
(2010-09 - 2013-05)
- Maintained study protocol knowledge and coordinated with investigators and monitors to ensure effective trial conduct, support feasibility and initiation activities
- Assisted in patient recruitment and screening per inclusion/exclusion criteria; managed IVRS randomization, visit scheduling, IP dispensing, and test procedures
- Maintained source documents, eCRFs, monitoring visit reports, and essential files; resolved queries and completed action items documented in MVR
- Handled data clarification forms, report SAE/AE to sponsor, DCGI, and ethics committee; maintain site binders, IP accountability, temperature logs, and shipping records
- Supported CRAs during remote monitoring and close-out visits; ensure compliance and timely issue resolution
