Senior Associate, TMF Management @Eisai Inc.

[Hiring] Senior Associate, TMF Management @Eisai Inc.

Mar 26, 2025 - Eisai Inc. is hiring a remote Senior Associate, TMF Management. 💸 Salary: unspecified. 📍Location: USA.

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Role Description

This role involves performing global management activities relating to electronic Trial Master Files (TMF), ensuring regulatory inspection-readiness and compliance with applicable laws and regulations.

Maintain and set up eTMF system, create and manage TMF Plan and filing expectations
eTMF Quality Issue resolution, eTMF user support, and assist with the oversight of the eTMF vendor
Initiate quality control reviews of eTMFs
Manage assigned studies; create and maintain the TMF Plan and TMF Index
Monitor document submissions and quality issues workflows
Deliver monthly Health reports/CRO metrics / Key Performance Indicators, along with strategy / summary of way to improve
Manage activities within electronic TMF Management system including: Study set-up, milestones, events, lifecycles
Oversee and monitor the completion of study / country / site Completeness reviews
Trigger Archival activities at the study close
Perform ad hoc system trainings and demos as required for TMF leads, assigned study teams and/or CRO Partners
Trigger and manage the activities related to archiving of TMF documents
Oversee the TMF Completeness activities associated with reviews / updates to the EDLs to ensure adherence to SOPS and regulatory requirements
Assist with generating various reports, metrics and analyzing trends across studies, countries, and sites
Oversee the project teams to ensure compliance with eTMF Processes/Procedures
Assist or initiate improvements of departmental SOPs, SWPs, work guidelines or trainings as needed

Qualifications

Bachelor’s degree in Health Administration, Management Information Systems, or closely related scientific or technical discipline
2 years of pharmaceutical industry experience in job offered or as Regulatory Documentation Specialist

Requirements

2 years of experience with/using TMF/eTMF ICH and GCP guidelines
Experience with PhlexEView and Veeva Vault
Delivering Health reports and CRO metrics

Company Description

Eisai is a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development.

Committed to satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers
History includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease
Fully integrated pharmaceutical business that operates in two global business groups: oncology and neurology
U.S. headquarters, commercial and clinical development organizations are located in New Jersey
Discovery labs are in Massachusetts and Pennsylvania
Global demand chain organization resides in Maryland and North Carolina

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📍	Be aware of the location restriction for this remote position: USA
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Senior Associate, TMF Management @Eisai Inc.

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Salary 💸 unspecified	Remote Location USA
Job Type full-time	Posted Mar 26, 2025

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📍	Be aware of the location restriction for this remote position: USA
‼	Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.

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[Hiring] Senior Associate, TMF Management @Eisai Inc.

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