Summary

Overview

Work History

Education

Skills

Certification

LEADERSHIP & STRATEGIC FOCUS AREAS

Timeline

Virginia Bellamy

Russellville,AR

Summary

Certified Clinical Data Manager (CCDM) and senior data management leader with extensive global experience building, optimizing, and governing clinical data standards across diverse therapeutic areas. Proven track record leading cross-functional and international teams, modernizing data operations, and implementing scalable, future-ready patient data strategies. Skilled in harmonizing standards, driving organizational alignment, engaging with external stakeholders, and integrating emerging technologies to elevate quality, efficiency, and regulatory compliance.

Overview

years of professional experience

Work History

Senior Director, Clinical Data Management

Inference Inc.

Chesterbrook, PA

04.2022 - Current

Lead global Data Management teams across the US and India, establishing consistent standards, workflows, and governance structures that support cross-functional collaboration.
Drive organization-wide data standardization initiatives including CRF libraries, edit check frameworks, data transfer specifications, and metadata conventions.
Represent the organization in sponsor/vendor working sessions to identify emerging best practices and introduce innovation into DM processes.
Spearhead modernization of patient data strategy, including integrations across EDC, eConsent, RTSM, CTMS, and eSource-adjacent platforms.
Establish and refine end-to-end processes for data flow integration, risk-based data review, and data quality oversight.
Provide hands-on leadership for the development of CTMS/eTMF/RTSM requirements, ensuring alignment with future data interoperability needs.
Coach and mentor global teams, building capabilities around standards, advanced EDC development, and compliant data pipelines.
Develop resource planning, financial forecasts, and operational roadmaps aligned with strategic DM and technology goals.

Director, Clinical Data Management

Cognitive Research Corporation

Saint Petersburg, FL

09.2018 - 04.2022

Led DM operations and enforced adoption of standardized processes across study teams, driving harmonization and inspection-readiness.
Implemented standardized edit check libraries, validation rules, and data review diagnostics to support consistent quality across programs.
Oversaw EDC development in Medidata Rave and Medrio, aligning databases to CDISC/CDASH conventions and sponsor governance.
Partnered with biostatistics and programming leadership to streamline data flow and expectations for analysis-ready data.
Evaluated and updated SOPs, integrating regulatory and technological expectations related to digital data capture and integrity.

Lead Data Manager

Applied Genetic Technologies (AGTC)

Alachua, FL

01.2018 - 08.2018

Oversaw vendor management and enforced DM standards across early-phase gene therapy programs.
Directed development of CRFs, edit checks, data transfer agreements, and audit plans in alignment with enterprise standards.
Led UAT for integrated EDC/IxRS systems, ensuring consistency with standardized workflows and metadata conventions.
Contributed to protocol and SAP development with a focus on data structure harmonization and traceability.

Research Analyst / Technical Lead

Comprehensive Health Insights

Louisville, KY

10.2015 - 06.2017

Developed standardized database (EDC), Data Management Plans, and Quality Management Plans supporting enterprise quality and compliance.
Identified systemic DM issues and implemented standardized processes to reduce variability and improve predictability across studies.
Served as project and client liaison, communicating data standards, metrics, and harmonization efforts.

Data Operations Leader

Parexel International

Durham, NC

10.2014 - 10.2015

Enforced global data standards and coordinated cross-functional data operations, delivering integrated outputs across programming, biostatistics, and clinical operations.
Designed and implemented standardized reconciliation and data dependency workflows.

Senior Clinical Data Manager

Atlantic Research Group

Charlottesville, VA

09.2013 - 10.2014

Developed and maintained Data Management Plans and ensured compliance across the study lifecycle.
Led eCRF design, user requirements, edit rule specifications, and UAT planning/execution.
Managed Data Transfer Agreements with external vendors and reconciled electronic data transfers.