Sr. Associate eTMF @Eisai Inc.

[Hiring] Sr. Associate eTMF @Eisai Inc.

Mar 25, 2025 - Eisai Inc. is hiring a remote Sr. Associate eTMF. 💸 Salary: $78,300 - $102,800. 📍Location: USA.

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more.

Role Description

The Senior Associate, TMF Management, is responsible for performing global management activities relating to electronic and paper Trial Master Files (TMF), ensuring regulatory inspection-readiness and compliance with applicable laws and regulations.

Manage assigned studies; create and maintain the TMF Plan and TMF Index, monitor document submissions and query workflows, and deliver monthly Health reports/CRO metrics/Key Performance Indicators.
Manage activities within electronic TMF Management system including study set-up, milestones/events, 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 assigned study teams and/or CRO Partners.
Trigger and manage the activities related to archiving of TMF documents, including obtaining approval from the study team, notifying the Eisai Archivist, and maintaining electronic logs which contain the location of study 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 the Eisai study team and outsourced CRO are compliant with eTMF Processes/Procedures and/or management for the correction and resolution of quality issues, TMF completeness and timely submission of documents to the TMF.
Assist or initiate improvements of departmental SOPs, SWPs, work guidelines or trainings as needed.

Qualifications

Bachelor’s degree in scientific or technical discipline recommended with minimum of 3-4 years of pharmaceutical industry experience (8+ years of hands-on TMF/document management experience will be considered in lieu of a Bachelor’s degree).
Preferred 1-2 years of experience in TMF/eTMF, clinical document management and/or clinical quality control.
Good understanding of clinical development, including regulatory documents and regulatory requirements (including ICH and GCP guidelines).
Experience/Knowledge/understanding of TMF requirements and technologies (such as PhlexEView and Veeva Vault) to support document collection and archiving; eTMF experience required.
Strong document management skills, including experience with review of Regulatory Documents, be detail-oriented, organized, quality-driven and able to work in a team environment under tight deadlines.
Good critical reasoning skills, including the identification and resolution of complex problems.
Must be proficient in MS Office.
Strong verbal, written and interpersonal communication skills.
Shows high level of initiative and has ability to work independently.
Very detail-oriented and excellent organizational and time management skills.

Requirements

Base salary range for the Sr. Associate eTMF is from $78,300 - $102,800.
This position is eligible to participate in the Eisai Inc. Annual Incentive Plan.
Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills.

Benefits

Employees are eligible to participate in Company employee benefit programs.
For additional information on Company employee benefits programs, visit Eisai Benefits .

Similar Remote Jobs

Kickstart Your Job Search

Need advice to apply? Join our free Webinar « 3 Mistakes to Avoid When Looking For A Remote Startup Job (And What To Do Instead) »

Unlock 53,518 additional remote jobs, advanced search & email notifications

Get Access Now

Too many emails? Declutter your inbox with Meco

Your home for reading newsletters

Try for free - no card required.

Before You Apply

️

📍	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.

Back to Remote jobs > All others

Sr. Associate eTMF @Eisai Inc.

All others

Salary 💸 $78,300 - $102,800	Remote Location USA
Job Type full-time	Posted Mar 25, 2025

Apply for this position Unlock 53,518 Remote Jobs

️

📍	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.

Sr. Associate eTMF Apply for this position Unlock 53,518 Remote Jobs

[Hiring] Sr. Associate eTMF @Eisai Inc.

Similar Remote Jobs

More jobs at Eisai Inc.

More All Others jobs

More jobs in USA

Kickstart Your Job Search

Get daily remote job opportunities in your inbox