Study Owner, eClinical Services

Position Summary:

The Study Owner (SO) forms part of the Client Services team within TransPerfects 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:

• Bachelors 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