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Kathleen Thiess

@kathleenthiess

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Records specialist lead with 14+ years optimizing clinical data, records, and compliance.

United States

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What I'm looking for

I seek roles where I can lead records/data teams, improve clinical data quality and compliance, mentor staff, and implement efficient processes.

I am a Records Specialist Lead and Clinical Database Designer with over 14 years of experience in data management, clinical database design, records management, and quality assurance. I focus on improving data accuracy, compliance, and retrieval efficiency across organizations.

In leadership roles I have managed teams, trained new staff, maintained SharePoint systems, and implemented process improvements that reduced errors and physical storage needs. I have designed eCRFs, validated clinical trial data, and produced comprehensive data export specifications to support seamless integration with client requirements.

My background includes hands-on roles in clinical database engineering and project quality, where I led SOP revisions, audit readiness, and GxP-aligned quality interventions that improved project outcomes. I have consulted with clients and cross-functional teams to align trial designs with objectives and deliver on-time project results.

I am committed to fostering a culture of accountability and continuous improvement, leveraging technical skills (including CDISC, SAS, Microsoft Office, and Exterro) and domain knowledge in clinical research to drive measurable operational gains.

Experience

Work history, roles, and key accomplishments

Current

Records Specialist Lead

Current

Constellis

Dec 2024 - Present (9 months)

Led a team of records specialists to streamline data management, improving retrieval times and accuracy while enhancing compliance and reducing physical storage through SharePoint implementation.

Records Management SharePoint)Data Governance Project Management Process Improvement Training & Compliance Document Control

Clinical Database Designer

Anju Software

Feb 2020 - Nov 2023 (3 years 9 months)

Managed client consultations and designed eCRFs and data export specifications for clinical trials, improving data integrity and delivering projects on time through cross-functional coordination.

CDISC Data Mapping EDC Consultation Data Validation Project Coordination GCP)

Clinical Database Designer

Parexel International

Dec 2014 - Feb 2020 (5 years 2 months)

Engineered ClinBase database solutions and CRF designs for early‑phase research, revised SOPs to meet regulatory standards, and ensured on-time database setup and study execution.

Database Design CRF Design CDISC Data Validation Project Management Clinical Research

President

Village of Silver Hall Community Association

Oct 2016 - Oct 2019 (3 years)

Led community initiatives and strategic planning, improved program execution and engagement, managed budgets and vendor payments, and introduced digital platforms to boost participation.

Budgeting Accounts Payable Vendor Management Strategic Planning Stakeholder Engagement Communication Event Coordination

Project Quality Lead

Parexel International

May 2014 - Dec 2014 (7 months)

Conducted project documentation reviews and led audit/inspection preparations, implemented quality interventions aligned with GxP, and supported CAPA and cross-functional quality communication.

Quality Assurance CAPA Documentation Review Regulatory Compliance Risk Mitigation