Elizabeth Setney
eTMF Specialist at Advanced Clinical- Claim this Profile
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English -
Topline Score
Bio
Credentials
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Good Clincal Practice Certification
NIDA Clinical Trials NetworkMar, 2023- Nov, 2024
Experience
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Advanced Clinical
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United States
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Biotechnology Research
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700 & Above Employee
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eTMF Specialist
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May 2023 - Present
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ICON plc
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Ireland
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Pharmaceutical Manufacturing
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700 & Above Employee
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Senior TMF Specialist
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Aug 2013 - Dec 2022
*Reviewed clinical study documents in preparation for filing in trial master file. *Prepared and index clinical study documents according to sponsor SOP. *Reviewed and distributed documents received in client specific mailbox to team of 8 TMF Specialists. *Provide education, feedback and guide Study Teams and other TMF Specialists in order to build knowledge and awareness of good document management practices and TMF for clinical trials. *Communicate directly with the Sponsors, Project Managers, monitors and other study contacts to ensure timely receipt and filing of the required TMF documents. *Performed reviews of the trial master file to confirm accurate filing of site records. *Prepare and provide status reports requested by management. *Assist in the creation of eTMF user guides and work instructions. *Participated in document archiving activities as necessary. Show less
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KinderCare Learning Companies
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United States
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Education Management
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700 & Above Employee
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Teacher
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Mar 2008 - Aug 2013
Teacher of Kindergarten students and after school program, regular conferences with parents and caregivers, classroom management, weekly assessments Teacher of Kindergarten students and after school program, regular conferences with parents and caregivers, classroom management, weekly assessments
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Allied Van Lines
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United States
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Transportation/Trucking/Railroad
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100 - 200 Employee
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Dispatcher
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Jan 1990 - Jun 1995
Dispatcher of local and long distance trucks
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Customer Service
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Jun 1983 - Jan 1990
Dispatching for delivery of special product equipment, providing estimate of cost to new and established customers
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Education
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Gwynedd Mercy University
Bachelor of Science (B.S.), Elementary Education and Teaching -
Middlesex County College
Associates of Arts, Liberal Arts and Sciences/Liberal Studies