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