Study Owner, eClinical Services

United Kingdom·Londonmid

OtherClinical

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Quick Summary

Overview

Position Summary: The Study Owner (SO) forms part of the Client Services team within TransPerfect´s Trial Interactive division, working on behalf of clients as an extension to their study team.

Technical Tools

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The Study Owner (SO) forms part of the Client Services team within TransPerfect´s Trial Interactive division, working on behalf of clients as an extension to their study team. The Study Owner ensures a complete, contemporaneous and accurate Trial Master File (TMF) and electronic TMF (eTMF) across our clients’ clinical programs. Working with client study teams and functional leads, they assume a key role in the management of a study with a focus on study start up and the TMF with the goal of supporting inspection readiness.

Responsibilities

~2 min read

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Participate in client Study Owner engagements and consistently deliver quality customer success
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Own and account for the TMF on behalf of our clients, across multiple studies and programs
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Support inspection readiness as a culture, and compliance with Good Clinical Practices (GCP) regulatory requirements
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Assist study teams with all study start up activities utilizing Study Start Up, Clinical Trial Management Systems (CTMS) and eTMF systems
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Assist study teams with all maintenance and close out activities utilizing systems such as, but not limited to, CTMS and eTMF systems
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Create study-specific TMF Plans on behalf of clients
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Help ensure TMF plan compliance
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Ensure compliance with client Standard Operating Procedures (SOPs) and work instructions
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Meet with study teams to understand events/activities that would impact the TMF
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eTMF ongoing user management
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May be responsible for creation and or maintenance of events/placeholders or equivalent in the eTMF
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Resolve outstanding TMF queries on behalf of clients
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Complete periodic TMF quality reviews, at agreed intervals, and ensure documentation is present/complete in the TMF
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Identify and report to study leads on TMF trending issues/concerns, determining resolutions and course of actions
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Identify continuous improvement opportunities to enhance TMF operational efficiencies
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Monitor and assess the overall health of the TMF
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Storyboard creation and maintenance to assist with inspection readiness
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Support Audits/Inspections as needed
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Complete all other tasks that are deemed appropriate for this role and assigned by the manager/supervisor