About the job
As a Study Owner (SO) within the Client Services team at TransPerfect's Trial Interactive division, you will act as an integral part of our clients' study teams. Your primary responsibility is to ensure the integrity, accuracy, and contemporaneity of the Trial Master File (TMF) and electronic TMF (eTMF) for our clients' clinical initiatives. Collaborating closely with client study teams and functional leads, you will play a critical role in managing studies with a strong emphasis on study start-up and TMF management to ensure readiness for inspections.
Key Responsibilities:
Engage with clients as a Study Owner, consistently delivering exceptional customer satisfaction.
Take ownership of the TMF on behalf of clients across multiple studies and programs.
Foster a culture of inspection readiness and ensure compliance with Good Clinical Practices (GCP).
Assist study teams in all study start-up activities utilizing Study Start Up, Clinical Trial Management Systems (CTMS), and eTMF.
Support study teams in maintenance and close-out activities using systems such as CTMS and eTMF.
Develop study-specific TMF Plans for clients.
Ensure compliance with TMF plans and client Standard Operating Procedures (SOPs).
Coordinate meetings with study teams to identify events and activities that may impact the TMF.
Manage eTMF user access and permissions continuously.

