About the job
As a key member of the Client Services team at TransPerfect's Trial Interactive division, the Study Owner (SO) acts as a vital extension to our clients’ study teams. This role is crucial in maintaining a thorough, up-to-date, and precise Trial Master File (TMF) and electronic TMF (eTMF) throughout our clients’ clinical programs. Collaborating closely with client study teams and functional leads, the SO plays an essential role in managing studies, particularly focusing on study initiation and TMF management to ensure inspection readiness.
Key Responsibilities:
Engage with clients as the Study Owner, consistently delivering excellent customer service and support.
Oversee the TMF on behalf of our clients, managing multiple studies and programs effectively.
Foster a culture of inspection readiness and ensure compliance with Good Clinical Practices (GCP) and regulatory requirements.
Assist study teams with all study initiation activities, utilizing Study Start Up, Clinical Trial Management Systems (CTMS), and eTMF systems.
Support study teams in all maintenance and closeout activities using CTMS and eTMF systems.
Develop study-specific TMF Plans for clients and ensure compliance with these plans.
Ensure adherence to client Standard Operating Procedures (SOPs) and work instructions.
Collaborate with study teams to assess events/activities impacting the TMF.
Manage ongoing user access for eTMF systems.

