Samantha McGrath

About Samantha McGrath

A motivated, versatile, and resilient Clinical Research Professional with extensive experience including: advising in protocol development, managing the protocol review processes, trial master file (TMF) document generation and maintenance, site management, site evaluation/qualification, site initiation, interim monitoring, remote monitoring, risk-based monitoring, site close out, GCP audits, budget management, vendor oversight, and clinical trial management. Therapeutic Areas: Neuroscience, Cardiovascular, Oncology, Hematology, Infectious Disease, Inflammation, and Metabolic Disorders. Additional Specialized Experience: Government Research, Investigator Initiated Studies, Military, Vulnerable and Pediatric Populations, Medical Device, CAR-T and Gene Therapy. Further expertise in the pharmacy industry and healthcare field. Each position has required an exceptional rapport with coworkers, vendors, professionals and patients.

Experience

1. Local Trial Manager

   Amgen

   Oct 2022 — Present

   Primary point of contact to lead, manage and oversee the conduct of clinical trials from study start-up to close out at a country level in accordance with ICH-GCP and other applicable local regulations. Maintains the quality and scientific integrity of clinical trials at a country level and actively collaborates with cross functional internal and external partners to ensure timely delivery, budget implementation of clinical trial results within the country.Partners with global and local teams to provide high level strategy and actively drives study progress and country level study delivery.Plans, manages, and oversees clinical study implementation in accordance with the global program strategy, through leadership with engagement of the cross-functional Local Study Team.Communicates country status (including timelines and results) to key partners including updates to relevant systems for transparency.Provides country level input into the Country Operational Plan and partners with the Development Feasibility Manager through feasibility and with the Global Clinical Managers to ensure local delivery of the study.Supports internal audit and inspection activities and contributes to CAPAs, including leading resolution of issues when appropriate e.g, vendor management.Assigns and delivers all study support staff and continually reviews country level risk mitigation to ensure study delivers to plan.

Education

• Niagara University

  Biology/Biological Sciences, General

  2007 — 2009

• Medaille University

  Bachelor’s Degree, Biology/Biological Sciences, General

  2009 — 2011