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TMF Associate

  • TFS
  • Full time
  • Poland
  • 22/04/2021

The Trial Master File Associate (TMF Associate) is part of the Clinical Operations Unit within TFS Clinical Development Services (CDS) and will function operationally as a member of the Study Team with the responsibility to create, organize , maintain and oversee the Trial Master File (TMF) according to company policies, SOPs, Work Instructions and regulatory requirements.


Responsibilities

  • Create the Study TMF Index as directed by the PM (Project Manager)
  • Create first draft of TMF Plan, implement changes after review, generate final version and distribute final version to the study team
  • Create TMF at Trial, Country and Site Level (paper TMF)
  • Request IT to create eTMF at Trial, Country and Site Level when TFS system is used
  • Inform to study team that TMF is created and ready for document submission
  • Actively follow up study team is submitting documentation following the process described in The TMF Plan
  • Actively collaborates in the training to study Team in regards to the TMF workflow and management
  • Act as contact person for study team to support on TMF doubts or TMF issues and support study team to ensure TMF is submission and inspection ready at all times
  • Set up the Investigator’s File
  • Maintain and follow up TMF status, Identify areas with missing documentation and inconsistencies and follow up with the study team finding’s resolution
  • Responsible to creates and maintain TMF tracker
  • Perform Quality Check of each document before filing in TMF and follow up issues until resolution
  • Actively taking part in Study Team meetings and updates on the SMF status
  • Assist and attend activities associated to quality controls, audits and regulatory inspections in relation to the TMF
  • Identify TMF quality issues and escalate it to the CRM(Clinical Research Manager)/ PM(Project Manager/Director and collaborate in the action plans development
  • Responsible for closing and returning the TMF to the Sponsor with the support of Study Team and ensuring GCP compliance
  • Follow up with Sponsor until Acknowledgment of receipt of TMF

Requirements

  • Bachelor’s Degree preferred
  • Knowledge of GCP/ICH guidelines
  • Good written and communication skills
  • Good organizational and multi-tasking skills
  • Good software and computer skills
  • Able to work in a fast paced environment with changing priorities
  • Able to effectively work in a team enviornment
  • Effective time management

Benefits

  • Additional 5 days paid vacation per year, in accordance with the Company’s vacation policy
  • Private Health Coverage
  • Global General Liability Insurance
  • Global Travel Insurance
  • Lunch allowance for office based employees

About TFS

We believe that a company with ethical and transparent values has a better chance of attracting skilled employees and building long-term relationships.

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