Study Owner, eClinical Services

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 ...