Study Owner, eClinical Services

2 weeks ago

City of London, Greater London, United Kingdom TransPerfect Full time £40,000 - £60,000 per year
Job description

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

Job requirements

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

Hybrid
  • London, Greater London, United Kingdom
Full-time, Permanent All done

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