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James Bass

@jamesbass

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I lead clinical data management and trial data operations across complex research programs.

United States

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At Pfizer, I lead Clinical Data Sciences activities for clinical trials, guiding data acquisition standards, data management plans, quality risk indicators, third-party data due diligence, and database release.

I partner with research teams, business units, service providers, and cross-functional stakeholders to deliver high-quality, inspection-ready data management while meeting study timelines and milestones.

Previously at Foundation Medicine, I supported BioPharma data operations through formal data transfers, reporting-system improvements, transfer specifications, reconciliation, genomic data collection, and team training. At Novartis, I helped develop clinical data systems, visualizations, and productivity tools.

Across more than 15 years in clinical research data operations, I've built and validated EDC systems, improved data quality processes, coached junior colleagues, and supported compliant work under ICH-GCP, CLIA, CAP, and applicable quality standards.

Experience

Work history, roles, and key accomplishments

Current

Manager, Clinical Data Scientist

Current

Pfizer, Inc.

Oct 2022 - Present (3 years 11 months)

Serve as Clinical Data Scientist and Trial Lead for clinical trials, responsible for all CDS activities including data acquisition standards, Data Management Plan, and quality risk indicators. Ensure quality database design, documentation, testing, and implementation of clinical data collection tools.

Clinical Data Management EDC Data Management Plans (DMPs)Quantitative and Qualitative Risk Indicators Trial Master File SOPs Data Cleaning Database Release Stakeholder Management ICH GCP Cross Functional Collaboration

Senior Associate, Senior Data Manager

Pfizer, Inc.

Jul 2019 - Oct 2022 (3 years 3 months)

Served as Lead Data Manager for clinical trials, accountable for end-to-end data management including standards selection, database design, data review, and database release. Coached junior data managers and ensured high-quality study documentation in the Trial Master File.

Clinical Data Management EDC Data Management Plans (DMPs)Data Cleaning Query Management Metrics Reporting Database Release TMF SOPs Coaching ICH GCP

Senior Clinical Data Manager

Foundation Medicine, Inc.

Mar 2018 - Apr 2019 (1 year 1 month)

Supported review and QA for data transfers to BioPharma partners and CROs, and worked with IT to test and implement improvements to data reporting systems. Provided leadership to Data Operations team and acted as key contact for strategic partnerships.

data transfers QA GCP CLIA CAP Data Reporting Leadership Training SOP Development Data Operations

Clinical Data Manager II

Foundation Medicine, Inc.

Dec 2015 - Feb 2018 (2 years 2 months)

Performed review and QA for data transfers to BioPharma partners and CROs, and partnered with IT to test and validate enhancements to data reporting systems. Developed data transfer specifications and supported ongoing studies with scheduled and ad hoc transfers.

data transfers QA GCP CLIA CAP Data Reporting Training Subject Matter Expert Data Operations

Clinical Information Specialist

Novartis Institutes for Biomedical Research

Sep 2013 - Dec 2015 (2 years 3 months)

Provided clinical information and systems support for Clinical Development groups, championed data systems and visualization, and developed tools for clinical data visualization. Acted as super user for data management systems and trained users.

Clinical Data Systems Data Visualization Programming SharePoint Training User Management

Clinical Investigational Data Analyst

Dana-Farber Cancer Institute

Dec 2011 - Aug 2013 (1 year 8 months)

Played an integral role in the collection, computerization, and quality assurance of clinical trial data. Developed and managed electronic data capture systems for clinical trial protocols, including forms design, database setup, and programming reports.

EDC Oracle SAS Clinical Trials Data Quality Database Management Reporting

Clinical Investigational Data Analyst

Dana-Farber/Harvard Cancer Center

Dec 2011 - Aug 2013 (1 year 8 months)

Played an integral role in collection, computerization, and quality assurance of clinical trial data. Developed and managed electronic data capture systems, designed forms, and prepared data for analysis.

EDC Oracle SAS Clinical Trials Data Quality Forms Design Database Management

Research Data Specialist

Sleep for Science Research Lab of E.P. Bradley Hospital and

Jun 2009 - Dec 2011 (2 years 6 months)

Assisted the Data Coordinator with management and organization of data projects, supervised data entry personnel, and trained research assistants on entry and error-checking processes.

Data Management Data Entry Supervision Training Quality Assurance

Research Data Specialist

Sleep for Science Research Lab of E.P. Bradley Hospital and

Jun 2009 - Dec 2011 (2 years 6 months)

Assisted the Data Coordinator with management and organization of data projects, supervised data entry personnel, and reviewed data for quality and completeness. Trained research assistants on entry and error-checking processes.

Data Management Data Entry Quality Review Training Supervision

Research Assistant II (Non-Lab)

Harvard University

Jan 2011 - Aug 2011 (7 months)

Recorded and coded data according to research protocols, processed and summarized data, and reported results using Microsoft Office. Implemented a new system for organizing files and data, and supervised interns.

Data Entry Data Coding Microsoft Office Research Protocols File Management Supervision Data Management