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Sarah Leer

@sarahleer

Clinical Project Manager at PCM Trials who directed 11 global studies and delivered Pfizer’s Paxlovid program across 20+ countries.

United States

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At PCM Trials, I directed up to 11 concurrent global Phase I–IV and decentralized studies, managing delivery from start-up through closeout. I owned project plans, budgets, risks, and sponsor reporting.

I led the Pfizer Paxlovid program across 20+ countries and 300+ sites under compressed timelines, earning a 10/10 client satisfaction score and supporting a contract extension. I also managed 12 direct reports and oversaw vendors, sites, and cross-functional study teams.

At Prime Path MedTech, I built the regulatory and project-tracking structure used to manage document status, ownership, timelines, risks, and client deliverables. My clinical operations experience also includes pharmacovigilance programs, Phase I–IV research coordination, and regulated pharmaceutical operations.

Experience

Work history, roles, and key accomplishments

Clinical Program Manager

Prime Path MedTech

Apr 2026 - May 2026 (1 month)

Led clinical program and regulatory operations in a start-up medtech/CRO environment, building the regulatory and project-tracking structure used to manage document status, ownership, timelines, monitoring activities, gaps, risks, and client deliverables.

Regulatory Operations Project Tracking Clinical Operations Cross functional Coordination Inspection Readiness

Clinical Project Manager

PCM Trials

Jul 2022 - Apr 2026 (3 years 9 months)

Directed end-to-end delivery of up to 11 concurrent global Phase I-IV and decentralized studies, managing 12 direct reports and leading a multimillion-dollar Pfizer Paxlovid program across 20+ countries and 300+ sites.

Clinical Operations Program Management Vendor Management Budget Management Risk Management CTMS ETMF EDC ICH GCP IRB Submission On Site Training Monitoring Oversight Inspection Readiness

Clinical Project Manager, Pharmacovigilance & Clinical Operations

ProPharma Group

Aug 2021 - Jul 2022 (11 months)

Managed client-facing clinical and pharmacovigilance programs supporting 10+ sponsors and approximately 50 trials, owning operational deliverables, timelines, client expectations, onboarding, invoicing, and service performance.

Pharmacovigilance Clinical Operations Client Management Safety Reconciliation Project Reporting To Sponsors Escalation Management

Clinical Research Coordinator

Indiana University School of Medicine

Dec 2020 - Aug 2021 (8 months)

Coordinated Phase I-IV neurology and rare neurodegenerative studies from site start-up through conduct, including IRB/regulatory submissions, informed consent, recruitment, source documentation, EDC/data quality, budgets, and invoicing.

Clinical Research IRB Submission Informed Consent Forms Recruitment EDC Data Quality Budget Management Neuropsychological Assessment Imaging Logistics Biospecimen Logistics

Pharmaceutical Specialist

Eli Lilly and Company

Aug 2019 - Dec 2020 (1 year 4 months)

Supported regulated pharmaceutical operations in a cGMP environment, including sterile manufacturing, aseptic/non-aseptic processes, packaging, batch documentation, quality procedures, safety requirements, TrackWise workflows, and continuous improvement.

GMP Sterile Manufacturing Aseptic Processing Packaging Batch Documentation Quality Procedures Trackwise Continuous Improvement

Clinical Research Assistant / CRA Support

Covance

Apr 2018 - Apr 2019 (1 year)

Supported early-phase clinical research and monitoring-related activities in a high-volume clinical environment, including participant-facing study procedures, protocol execution, source/documentation quality, data collection, specimen logistics, and coordination across clinical research teams.

Clinical Research Protocol Execution Data Collection Sample Logistics Source Documents Team Coordination