Summary
Overview
Work History
Education
Skills
Websites
Certification
THERAPEUTIC EXPERIENCE
Timeline
Generic

PATRICIA MATTHEWS

Holly Springs,NC

Summary

Motivated and customer-focused with over 20 years of clinical research and pharmaceutical industry experience. Deep expertise in managing all phases (I–IV) of clinical trials across global regions (North America, APAC, Europe, Latin America). Proven success in site feasibility, selection, activation, and regulatory submission strategy. Successfully led diverse teams to achieve project goals through cross-functional leadership, strategic planning, and delivering compliant site activation in high-complexity therapeutic areas including oncology, urology, rare disease, and infectious diseases.

Overview

22
22
years of professional experience
1
1
Certification

Work History

Principal Start-Up Team Manager

Thermo Fisher Scientific (formerly PPD)
10.2021 - Current
  • Oversaw global SSU activities from site feasibility to activation, including CDA collection, questionnaires, IRB/EC submissions, and IMP release.
  • Developed SSU strategies and maintained operational oversight across complex global studies.
  • Collaborated cross-functionally to ensure timely and compliant site activations across multiple regions.
  • Led site activation forecasting and supported mitigation strategies to meet key milestones.
  • Directed the preparation of essential document templates and supported regulatory submission content.
  • Provided oversight of study startup budget and resource alignment, including vendor coordination.
  • Reviewed and approved IMP release packages and supported ICF negotiations and escalation processes.

Senior Start-Up Team Manager

Thermo Fisher Scientific (formerly PPD)
05.2014 - 04.2021
  • Led global and regional site startup across therapeutic areas, managing multiple concurrent trials.
  • Delivered regulatory strategies aligned with project goals and global startup targets.
  • Served as the primary liaison for startup deliverables with sponsors and internal stakeholders.

Start-Up Team Manager

Thermo Fisher Scientific (formerly PPD)
10.2008 - 04.2014
  • Managed operational startup from feasibility through site activation.
  • Established timelines, coordinated functional teams, and ensured global SOP and GCP compliance.

Clinical Research Associate

Thermo Fisher Scientific (formerly PPD)
07.2004 - 09.2008
  • Monitored site activities across all phases, ensuring adherence to protocol and regulatory requirements.
  • Conducted site visits and collaborated with investigators and sponsor teams.

Clinical Research Associate

Rho, Inc.
06.2003 - 07.2004
  • Executed monitoring visits and reviewed regulatory documents for FDA and ICH compliance.
  • Supported site readiness and protocol adherence in early-phase trials.

Education

B.S. - Biology

North Carolina State University
Raleigh, NC
05.2000

Skills

  • Veeva Vault eTMF
  • Siebel CTMS
  • Microsoft Office
  • Crystal Reports
  • Oracle
  • Lawson

Certification

Certified Clinical Research Associate (CCRA) – Association for Clinical Research Professionals

THERAPEUTIC EXPERIENCE

  • Oncology (Breast, Prostate, Lymphoma, Multiple Myeloma)
  • Infectious Disease (COVID-19, HIV, Asthma)
  • Cardiovascular (Atrial Fibrillation, Angioedema, Heart Failure)
  • GI, Neurology, Hematology, Rare Disease, Cell Therapy

Timeline

Principal Start-Up Team Manager

Thermo Fisher Scientific (formerly PPD)
10.2021 - Current

Senior Start-Up Team Manager

Thermo Fisher Scientific (formerly PPD)
05.2014 - 04.2021

Start-Up Team Manager

Thermo Fisher Scientific (formerly PPD)
10.2008 - 04.2014

Clinical Research Associate

Thermo Fisher Scientific (formerly PPD)
07.2004 - 09.2008

Clinical Research Associate

Rho, Inc.
06.2003 - 07.2004

B.S. - Biology

North Carolina State University

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