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 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

Essential skills required

• Superior written and spoken communication skills in English (written and verbal)
• Strong presentation skills
• Ability to effectively multitask in order to simultaneously execute multiple projects
• Proactive and able to work on own initiative
• Exceptional problem-solving/critical thinking skills
• Detail-orientated and well organized

Required experience and qualifications

• 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
• International Council for Harmonization (ICH)/GCP knowledge and understanding
• Experience working with eTMF or other eClinical systems such as Veeva Vault or Wingspan IQVIA TMF

Desired skills and experience

• Good interpersonal skills
• Ability to build relationships with clients and co-workers
• Knowledge of additional languages at professional working proficiency

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