Worldwide Clinical Trials

Senior Associate I, TMF Operations

Worldwide Clinical Trials

full-time

Posted on:

Location Type: Remote

Location: United Kingdom

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Job Level

Senior

About the role

  • Perform RMC Lead Activities for 1-3 Studies
  • Support TMF set-up, coordinate ‘Requests for Sites to be added in eTMF’ between Project Teams (PT) and eTMF administrators
  • Review eTMF access and coordinate updates, as necessary
  • Provide Subject Matter Expert (SME) support for Project Teams and Sponsor related to TMF
  • Oversee the QC process and make sure the RMC is on track (compliant with timelines and documentation) and follow up on non-compliance accordingly
  • Prepare, maintain, and share TMF metrics and spreadsheets for assigned studies with Project Teams and Sponsors
  • Review TMF Key Performance Indicators (KPIs) and ensure that TMF KPIs are in compliance
  • Support Regulatory and Sponsor audits and audits finding resolution, where necessary

Requirements

  • University Degree preferred (Life Science desirable)
  • 1-3 years of relevant experience
  • Knowledge of working within a highly regulated industry or experience of CRO/Pharmaceutical Industry
  • Excellent written and verbal communication skills
  • Strong interpersonal skills
  • Ability to handle multiple, highly detailed tasks with exceptional accuracy
  • Strong planning and organizational skills
  • Proficiency in Microsoft Word and Excel
Benefits
  • Health insurance
  • Professional development opportunities
  • Flexible working hours
  • Remote work options
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
TMF managementQC process oversightKPI reviewmetrics preparationdata analysis
Soft Skills
written communicationverbal communicationinterpersonal skillsorganizational skillsplanning skillsattention to detail