Shweta Bhende

Clinical operations professional with 10+ years of experience supporting global Phase II–III clinical trials across CRO and site environments. Strong expertise in centralized and risk-based monitoring (RBM), global study oversight, TMF compliance, budget/EAC management, vendor management and inspection readiness. Proven leader experienced in cross-functional collaboration, people management, and delivering high-quality, compliant trial execution.

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

M. Pharm - Pharmacology - RTM University (2015)

Advanced Diploma - Clinical Research - MSBTE (2010)

B. Pharm - RTM University (2009)

D. Pharm - MSBTE (2005)