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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

Clinical Trials TMF Specialist/Clinical Trials Study Team Associate


Reference:SCAVWU-082387 Location: Dublin
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Clinical Project Manager, Clinical Research Associate, Clinical Trials Assistant

Clinical Trials TMF Specialist/Clinical Trials Study Team Associate
Our client, a very exciting biopharma start-up are currently expanding their Clinical Trials team and are recruiting for a TMF Specialist/Clinical Trials Study Team Associate to join them on a permanent basis. The ideal candidate will have four years’ TMF management experience, both paper and electronic and naming and filing conventions reviews. Experience using Veeva Volt is essential. This role is ideal for someone who would be interested in working 4 days per week. This will be a hybrid working role also.

Responsibilities

  • Serve as point of contact for the migration study teams for TMF matters, and liaise with the other TMF Subject Matter Experts (SMEs) and process owners to help their understanding of requirements and associated solutions to ensure the migrated TMFs are inspection ready
  • Within TMF, you will be responsible for Indexing, Post-Migrating Remediation, changing the TMF to e-TMF, Auditing TMF, Meeting Metrics for documentation, QC Checks & Archiving.
  • QC of documentation identifying missing documents and compiling tracking sheets in accordance with agreed processes
  • Liaise with investigational site staff regarding end of trial archiving requirements
  • Support project teams through (e)TMF and study document management, vendor management, assist with regulatory and ethics submissions
  • Manage trial supplies
  • Liaise with our insurance provider and maintain a tracker of all country insurances
  • Proactively assist Project Managers in running of clinical studies
  • Set up project tracking tools and ensure they are used efficiently
  • With the support of the Clinical PM create project specific oversight plans
  • Make track changes during SOP reviews
  • Set up and maintain electronic filing system for all projects
  • Create and maintain study contact lists for team/sites/3rd parties
  • Management of ClinTrials.gov and EU Clinical Trials Register
  • Work closely with the Study Managers to organize and execute clinical conduct activities
  • Schedule meetings and manage travel arrangements
  • Participate in team meetings, including cross-functional team meetings and meetings with third party vendors and document meeting minutes
Requirements
  • Degree in Life Science
  • 4 years TMF management experience
  • Familiar with small working environments, with experience of working in a Biotech setting
  • Proficient at communicating with study teams/colleagues both internally and externally
  • Experience in QC, maintenance of trial tracking sheets and databases and of preparing documentation for archiving
  • Thorough knowledge of ICH/ GCP standards
  • Proficient with different electronic data capturing (EDC) systems
  • Experience using Veeva Volt
For more information contact Sinéad Cullen on +353879500821 or [email protected]