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