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Pam Minton

@pamminton

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Clinical Data Manager focused on high-quality, compliant trial data and efficient validation pipelines.

United States

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What I'm looking for

I’m looking for a Clinical Data Manager role where I can protect data quality and integrity end-to-end, lead GCP/ICH-compliant validation and SDTM transfers, partner closely with stakeholders, and drive practical process improvements that deliver on timelines.

I’m an expert in ensuring the quality and integrity of clinical trials, with 20 years of experience across pharmaceutical companies and CROs. I combine clinical trial management with data collection, entry, validation, and analysis, including programming and testing EDC applications. I’m known for communicating effectively with stakeholders and mentoring study team members to keep study work moving with clarity and confidence.

In recent roles as a Senior Clinical Data Science Lead, I’ve led Oncology data management activities in alignment with GCP and ICH guidelines—overseeing CRF design, database development, external data processing, and data cleaning/coding to resolve queries effectively. I also drive end-to-end deliverables, including timely SDTM transfers and key documents such as Data Management Plans, Data Validation Plans, and Data Transfer Agreements, while maintaining transparency through metrics and thorough subject data review. From reconciling lab transfer data with vendors to maintaining TMF readiness, I focus on actionable insights and process improvements that raise data quality while meeting timelines and budgets.

Experience

Work history, roles, and key accomplishments

Senior Clinical Data Science Lead

Caidya

Jun 2024 - Feb 2025 (8 months)

Led Clinical Data Management activities for Oncology projects, ensuring adherence to GCP and ICH guidelines. Oversaw CRF design, database development, external data processing, and data review (including adverse events and medical history) while resolving queries and discrepancies with clients.

Clinical Data Management CRF Design Database Development Data Validation Coding And Query Resolution

Senior Clinical Data Science Lead

ICON

Mar 2022 - Jun 2024 (2 years 3 months)

Delivered on-time transfer of SDTM deliverables (aCRF, SDTM datasets, and Define.xml) and served as primary client liaison for CRF and source document completion. Developed, implemented, validated, and maintained data management deliverables (eCRFs, DMP, data validation plan, DTA) while coordinating validation programs and managing offshore teams to meet timelines and quality goals.

SDTM ACRF And Define.Xml Data Validation CRF And Source Document Completion GCP Driven Data Management

Clinical Data Manager II

PRA Health Sciences

Aug 2019 - Feb 2022 (2 years 6 months)

Served as primary client liaison for data management issues and ensured timely delivery of eCRF data entry screens. Managed query resolution, clinical database lock, and electronic data transfers to sponsors, while executing data validation programs, performing QC/reconciliation, and delivering on-time SDTM submissions.

Database Lock Query Management Data Validation CRF And Source Document Completion Data Transfer Agreement (DTA) Development Documentation Management Client Relationship Management

Clinical Data Manager II

PPD

Mar 2019 - Jun 2019 (3 months)

Acted as a lead data manager and liaison to the PM and/or client for one or more studies, applying protocol components to daily data management tasks. Monitored study metrics, escalated risks per PPD processes, led high-volume/highly complex studies, and mentored junior staff while supporting forecasting and budget oversight.

Protocol To Day Tasks Execution Status Reporting

Clinical Data Manager

Hurley Consulting Associates Ltd.

Aug 2016 - Feb 2019 (2 years 6 months)

Provided clinical data management support to clinical operations, study projects, data management, and biostatistics teams. Developed and maintained data management plans and specifications, supported eCRF design and UAT, created data listings/tables/reports for review and lock, and supported sponsor presentations and systems compliance documentation.

Edit Checks And Query Logic Data Tables TMF Regulatory Documentation Compliance

Education

Degrees, certifications, and relevant coursework

University of Phoenix

Bachelor of Science, Health Care Management

Earned a Bachelor of Science in Health Care Management. Completed coursework in healthcare management fundamentals.

University of Phoenix

Associate degree, Business

Earned an associate degree in Business. Completed foundational coursework in business disciplines.

Raritan Valley Community College/Barnett International

Certification, Clinical Data Management

Activities and societies: Protocol design and development; case report form design; data tracking and collection; data validation and queries; QC/QA and data reporting; database release; adverse experience reporting; remote data capture; managing mega-trials; managing CROs.

Completed NJSNA Clinical Data Management Skills training/certification. Covered protocol design, CRF design and development, data tracking, validation, QC/QA, adverse event reporting, and remote data capture.

Raritan Valley Community College/Barnett International

Certification, Clinical Research (CRA/CRC)

Activities and societies: CRA/CRC roles; FDA and GCP guidelines; IRB and consent forms; site selection and budget negotiation; study initiation and monitoring; audits and inspections; AE definitions and reporting requirements.

Completed NJSNA CRA/CRC certification training. Reviewed CRA/CRC roles, drug development, FDA and GCP guidelines, site selection and study monitoring, and regulatory compliance.

The Chubb Institute

Certification, Technical / Data Center Support

Activities and societies: AS/400-OS/400 work management; AS/400 control language (CL); JCL utilities; PC MS-DOS installation/configuration; Windows 3.1 administration; Norton Utilities; MS-Word, MS-Excel, and Access; Microsoft Plus.

Completed a technical/data center support certification. Trained in AS/400 operations, programming and job control language, and PC/Windows administration and utilities.