TMF Study Owner

TransPerfect Is More Than Just a Job…
Our greatest asset is our people, and nothing is more important to us than ensuring that everyone knows that. Each of our 90+ offices has its own individual identity, and each also has its own unique rewards.

TransPerfect Trial Interactive (TI) is seeking outstanding and diverse candidates to help our clients operate more effectively in the changing clinical environment. If you have a sense of urgency, a passion for organization, and a desire to help the world's leading global firms conduct business more effectively, TransPerfect Life Sciences could be the place for you.

We are looking for a Trial Master File (TMF) Study Owner (SO) to ensure a complete, contemporaneous and accurate TMF across our clients’ clinical trials and programs. This is an exciting opportunity to work with client study teams and functional leads, assuming a key role in the management of the TMF with a focus on supporting inspection readiness. If you are interested in pursuing a career with TransPerfect’s Trial Interactive division, with opportunities for growth and development in the eClinical industry, we look forward to hearing from you.

• Ownership and accountability for the TMF for our clients, across multiple studies and programs

• Support inspection readiness as a culture, and compliance with GCP regulatory requirements

• Assist study teams with all start up, maintenance and close out activities in regards to the TMF

• Set up eTMF system requirements (configuration, eTMF Index, expected documents, users etc.)

• eTMF ongoing user management

• Creation of study specific TMF Plans

• Ensure TMF plan compliance

• Ensure compliance with client SOPs and work instructions

• Meet with study teams to understand events/activities that would impact the TMF

• May be responsible for creation and or maintenance of events/placeholders or equivalent in the eTMF

• Drive TMF queries to resolution

• Complete TMF quality reviews at agreed intervals & 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

• Identification of continuous improvement opportunities to enhance TMF operational efficiencies

• Monitoring and assessing the overall health of the TMF

• Provide support and guidance to study teams to drive performance against TMF KPIs- completeness, quality and timeliness, using reports and metrics

• Training, feedback and support to study teams to build knowledge and awareness of good document management practices

• Storyboard creation and maintenance to assist with inspection readiness

• Support Audits/Inspections as needed

• Creative thinker – You are curious and unafraid to ask questions

• Hard worker – You are industrious and diligent in everything you do

• Innovator – You are willing to initiate changes and introduce new ideas

• Bachelor's degree preferred

• Minimum 3 years’ relevant experience:

  • 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

  • ICH/GCP knowledge and understanding

  • Experience working with eTMF or other eClinical systems such as Veeva Vault or Wingspan IQVIA TMF

  • Working familiarity with the TMF Reference Model

• Background in provision of high levels of customer service in client facing roles

• Achievement in building strong customer relationships

• Working across international boundaries and cultures

• Achievement in negotiation and conflict resolution, and working in high-stress situations

• Must have attention to detail

• Exceptional written and oral communication skills

• Excellent analytical abilities