MEGHANA VISHWESHWARA

Led and managed end-to-end data management activities across global Phase 3 clinical trials, ensuring data quality and compliance with ICH-GCP and regulatory guidelines (FDA, EMA).

Oversaw CRF/eCRF design, edit checks, data validation, and database lock processes to meet study timelines and milestones.

Collaborated closely with sponsors, CROs, and external vendors to align data deliverables and expectations across international trial sites.

Worked independently in a fully remote, cross-functional team environment, delivering consistently under tight timelines.

• Led a team of 5 members as a Data Operations Coordinator (DOC) ensuring seamless collaboration and reliability
• Oversaw data operations for Phase 1 & Phase 3 clinical trials within the Oncology therapeutic area.
• Represented the CDM function within clinical study teams, advocating for DM needs and constraints, on project advances and issues
• Managed Trial Master File (TMF) maintenance ensuring regulatory compliance throughout trials.
• Crafted project-specific documents, including data management plans and eCRF specific guidelines, contributing to project success.
• Oversaw external vendor activities and reported on DM task status to Study and Submission Teams
• Experienced in risk-based monitoring studies, applying proactive strategies to mitigate potential risks and ensure data integrity throughout the trial lifecycle.
• Ensured compliance of DM deliverables with client rules and standards, as well as meeting requirements from clinical study protocols and statistical analyses.
• Implemented rigorous quality control measures in data management processes to ensure accuracy, completeness, and regulatory compliance
• Executed manual database locking & freezing procedures with precision and attention to detail, ensuring data integrity and regulatory compliance throughout the study lifecycle
• Generated statistics, status reports, final reports & managed data queries.
• Supported team members by addressing data clarifications and facilitating documentation standards.
• Generated SAS discrepancy listings and performed manual discrepancy reviews.

• Managed diverse clinical trials spanning Oncology, Cardiovascular, Respiratory, Diagnostics, Musculoskeletal, and Devices.
• Led a team of 4-5 members as Lead Data Reviewer, facilitating seamless collaboration among sponsors, external providers and project teams.
• Actively contributed to CDM including eCRF setup, validation, and edit check creation.
• Facilitated User acceptance testing (UAT) procedures for EDC systems, addressed project-related queries and provided solutions to ensure smooth project execution.
• Proficient in various Electronic Data Capture (EDC) systems like Medidata Rave, IBM ECOES, Oracle inform and iMedNet.
• Successfully reconciled Serious Adverse Events (SAE) and protocol deviations.
• Generated study metrics and reports to support decision making and addressed protocol deviations in compliance with regulations.
• Successfully collaborated with stakeholders to facilitate trial progression across various phases and therapeutic areas, while also implementing quality control measures and providing mentorship in Clinical data management practices.