Worldwide Clinical Trials

Associate I – TMF Operations

Worldwide Clinical Trials

full-time

Posted on:

Location Type: Remote

Location: Poland

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About the role

  • Fulfil the "TMF Approver" role as defined by the relevant Standard Operation Procedure(s) (SOP) and working practices.
  • Process, review, and resolve rejected Trial Master File (TMF) documents, for multiple studies both in an electronic and hard copy format.
  • Work with a variety of Electronic Document Management and electronic TMF Systems to review, classify and process Essential Documents.
  • Communicate directly with RMC Lead to report trends and issues relevant to the TMF.
  • Escalate any TMF Quality issues in a timely manner to RMC Lead.
  • Provide administrative support for the RMC Lead including but not limited to filing and maintaining internal documents on study SharePoint (TMF Quality Control checklists and different trackers).
  • Perform additional tasks as assigned by their Line Manager.

Requirements

  • Possess data collection, indexing and editing skills, including ability to adhere to standardized document naming conventions.
  • Possess excellent written and verbal communication skills to clearly and concisely present information.
  • Work with internal teams and can execute tasks under general direction, seeks assistance as needed.
  • Exercise sound judgment and ability to identify decisions requiring supervisory approval.
  • Demonstrate proficiency in Microsoft Word and Excel.
  • Develop proficiency in use of an electronic document repository or eTMF, and document recognition skills.
  • General understanding of clinical research principles and processes.
  • University Degree preferred (Life Science desirable)
  • Up to 0-1 year of relevant experience
  • Knowledge of working within a highly regulated industry (desirable)
Benefits
  • Competitive salary
  • Flexible working hours
  • Professional development budget
  • Home office setup allowance
  • Global team events

Applicant Tracking System Keywords

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

Hard skills
data collectionindexingeditingdocument naming conventionsMicrosoft WordMicrosoft Excelelectronic document repositoryeTMFdocument recognition
Soft skills
written communicationverbal communicationsound judgmentdecision makingteam collaborationtask execution