Meghan Francis
Clinical Study Manager at Lexitas Pharma Services, Inc.
- Role
- Clinical Study Manager at Lexitas Pharma Services
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Meghan Francis
A Master of Public Health (MPH) and a combined 12 years of research experience, including 7 years in clinical research and 5 years of benchwork translational biomedical research. Meticulous organization skills that allow an approach complex problems and develop a plan of action and timeline to achieve success of a project. Primary therapeutic indication is ophthalmology, specifically anterior segment.
Experience
Clinical Study Manager
Jun 2022 — Present · Boston, MA, US
Responsible for the day-to-day management of project activities and deliverables; ensuring that the quality of interactions and communications across the project are consistent with the Sponsor and company expectations. • Serves as a liaison with the sponsor and vendors across all functional areas of the project; provides guidance to CLs, CRCs, CRAs, and CTAs. • Assists in managing the project, ensuring that the quality of interactions and communications across the project are consistent with the sponsor and department expectations. • Develops key study documents, including: Clinical Management Plans, Protocol Deviation Guidance Plans, ICFs, CRFs, ISFs, and source document templates. • Provides guidance to reviewer of monitoring visit reports. • Serves as a study contact for Sponsor and project vendors. • Manages study budget and timelines; negotiates and finalizes budgets and CSAs with sites; identifies, resolves or escalates issues involving study timelines, change orders, and deliverables. • Develops, implements, and oversees enrollment plans and strategies. • Collects, tracks, and reports established KPIs such as query resolution, safety data collection or issues, drug reconciliation/shipment, site and patient enrollment, and protocol deviations. • Identifies and establishes the suitability of study investigators and their investigative sites and liaises with them to ensure compliance with all necessary study requirements, approvals, and agreements. • Ensures study conduct in accordance with appropriate SOPs, ICH/GCP Guidelines, and local regulations.
Education
West Liberty University
Bachelor's Degree, Biology/Biological Sciences, General
2008 — 2012
Des Moines University
Master of Public Health - MPH, Public Health
2014 — 2016
University of Iowa
Immunology Graduate Coursework
2012 — 2013
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