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:
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Participate in client Study Owner engagements and consistently deliver quality customer success
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Own and account for the TMF on behalf of our clients, across multiple studies and programs
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Support inspection readiness as a culture, and compliance with Good Clinical Practices (GCP) regulatory requirements
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Assist study teams with all study start up activities utilizing Study Start Up, Clinical Trial Management Systems (CTMS) and eTMF systems
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Assist study teams with all maintenance and close out activities utilizing systems such as, but not limited to, CTMS and eTMF systems
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Create study-specific TMF Plans on behalf of clients
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Help ensure TMF plan compliance
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Ensure compliance with client Standard Operating Procedures (SOPs) and work instructions
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Meet with study teams to understand events/activities that would impact the TMF
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eTMF ongoing user management
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May be responsible for creation and or maintenance of events/placeholders or equivalent in the eTMF
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Resolve outstanding TMF queries on behalf of clients
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Complete periodic TMF quality reviews, at agreed intervals, and ensure documentation is present/complete in the TMF
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Identify and report to study leads on TMF trending issues/concerns, determining resolutions and course of actions
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Identify continuous improvement opportunities to enhance TMF operational efficiencies
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Monitor and assess the overall health of the TMF
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Storyboard creation and maintenance to assist with inspection readiness
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Support Audits/Inspections as needed
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Complete all other tasks that are deemed appropriate for this role and assigned by the manager/supervisor
Essential skills required:
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Superior written and spoken communication skills in English (written and verbal)
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Strong presentation skills
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Ability to effectively multitask in order to simultaneously execute multiple projects
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Proactive and able to work on own initiative
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Exceptional problem-solving/critical thinking skills
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Detail-orientated and well organized
Required experience and qualifications:
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Bachelor´s degree or equivalent
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3 years+ of experience in the Life Sciences industry (pharmaceutical, biotechnology or CRO experience preferred)
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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
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International Council for Harmonization (ICH)/GCP knowledge and understanding
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Experience working with eTMF or other eClinical systems such as Veeva Vault or Wingspan IQVIA TMF
Desired skills and experience:
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Good interpersonal skills
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Ability to build relationships with clients and co-workers
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Knowledge of additional languages at professional working proficiency
