Loretta Waters-Falzo
@lorettawatersfalzo
Adaptable Senior Project Specialist
What I'm looking for
Experienced project specialist with a track record of success in managing clinical trial documentation and ensuring compliance with SOPs. Skilled in coordinating project teams and activities to ensure timely and high-quality delivery of project deliverables.
Adept at maintaining Trial Master Files (TMF) and Clinical Trial Management Systems (CTMS) to support study success and drive cost efficiency. Collaborative and detail-oriented, with expertise in managing vendor relationships and ensuring document management compliance.
Proven experience in project management, risk management, process improvement, and project planning, with a strong background in cross-functional collaboration, communication, time management, and training.
Experience
Work history, roles, and key accomplishments
Senior Project
Syneos Health
Jan 2023 - Jan 2024 (1 year)
Managed clinical trial documentation and ensured compliance with SOPs
Clinical Project
Syneos Health
Jan 2019 - Jan 2023 (4 years)
Provided administrative and trial support for clinical projects
Senior Clinical
Source One Technical Solutions / Novartis
Jan 2018 - Jan 2019 (1 year)
Maintained Trial Master File and Clinical Trial Management System
Clinical Trial
Syneos / Immunomedics, Inc
Jan 2018 - Jan 2018 (0 months)
Maintained TMF and tracked study management data
Associate Clinical
Galmed Pharmaceuticals
Jan 2016 - Jan 2018 (2 years)
Managed clinical study documents in the eTMF
Education
Degrees, certifications, and relevant coursework
Bergen Community College
Certificate, Project Management
Completed Project Management I and II Certificate programs, focusing on essential project management skills and methodologies applicable in various industries.
Tech stack
Software and tools used professionally
Availability
Location
Authorized to work in
Job categories
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