Study Owner, eClinical Solutions

1 week ago

London, United Kingdom TransPerfect Full time

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.

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
Help ensure TMF plan compliance
eTMF ongoing user management
Complete periodic TMF quality reviews, at agreed intervals, and ensure documentation is present/complete in 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

Superior written and spoken communication skills in English (written and verbal)
Ability to effectively multitask in order to simultaneously execute multiple projects
Bachelor´s degree or equivalent
~3 years+ of experience in the Life Sciences industry (pharmaceutical, biotechnology or CRO experience preferred)
~ Document management/TMF related industry experience in order to have a thorough understanding of the processes associated with the conduct of clinical trials and document management operations
~ Ability to build relationships with clients and co-workers
Knowledge of additional languages at professional working proficiency


TransPerfect provides equal employment opportunities to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by local law.

We celebrate diversity as one of our core values and we have a clear goal: to be an inclusive workplace where a diverse mix of talented people want to come, stay and do their best work. Together with passionate, creative and collaborative colleagues, we are working to ensure accessibility is for everyone.

By applying, I confirm I have read and accept TransPerfect's Privacy Policy:

  • Study Owner, eClinical Solutions

    1 week ago

    London, United Kingdom TransPerfect Full time

    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...

  • Study Owner, eClinical Solutions

    1 week ago

    London, United Kingdom TransPerfect Full time

    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...

  • Study Owner, eClinical Services

    3 days ago

    London, Greater London, United Kingdom Perfect Fit Full time

    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...

  • eClinical Project Manager

    12 hours ago

    London, Greater London, United Kingdom Medpace Full time

    Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based eClinical Project Manager to join our Data Management team in Central London. The eClinical Project Manager role at Medpace is acrucial component of the clinical trial process.This role will work with both local and international teams and will manage global...

  • Lead eClinical Systems Analyst

    2 days ago

    London, Greater London, United Kingdom Perfect Fit Full time

    Position Summary:The Lead eClinical Systems Analyst is a senior line management role within TransPerfect´s Trial Interactive division. They are responsible for assisting clients with the development, maintenance and closeout of clinical trials, using a number of eClinical systems including but not limited to: eTMF, Study Start up (SSU) and Clinical Trial...

  • Lead eClinical Systems Analyst

    2 weeks ago

    London Area, United Kingdom TransPerfect Full time

    Position Summary: The Lead eClinical Systems Analyst is a senior line management role within TransPerfect´s Trial Interactive division. They are responsible for assisting clients with the development, maintenance and closeout of clinical trials, using a number of eClinical systems including but not limited to: eTMF , Study Start up (SSU) and Clinical Trial...

  • Senior Biostatistician

    2 weeks ago

    London, United Kingdom eClinical Solutions, LLC Full time

    eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud - the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location...

  • eClinical Coordinator

    2 weeks ago

    Greater London, United Kingdom Medpace Full time

    Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based eClinical Coordinator to join our Data Management team in Central London. The eClinical Coordinator at Medpace is a crucial component of the clinical trial process. By working with the eClinical Project Manager and other team members, these professionals...

  • Senior eClinical Business Lead, IRT/DHT design

    2 weeks ago

    London, United Kingdom Parexel Full time

    Parexel is currently seeking a Senior eClinical Business Lead, IRT/DHT design to join us in the UK. Picture Yourself At Parexel: The role provides consultation on the Randomization and Trial Supply Management (RTSM) and Digital Health Technology (DHT e.g., eCOA, eConsent) system design, analysing study protocols and collaborating with stakeholders to create...

  • Senior eClinical Business Lead, IRT/DHT design

    2 weeks ago

    Uxbridge, Greater London, United Kingdom Parexel Full time

    Parexel is currently seeking a Senior eClinical Business Lead, IRT/DHT design to join us in the UK. Picture Yourself At Parexel: The role provides consultation on the Randomization and Trial Supply Management (RTSM) and Digital Health Technology (DHT e.g., eCOA, eConsent) system design, analysing study protocols and collaborating with stakeholders to create...