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