Short-Term Clinical Trial Archiving Assistant (CTAA)

IDDI (International Drug Development Institute)a Biostatistical and eClinical services provider in the field of clinical research is looking for a Clinical Trial Archiving Assistant CTAA to assist the project managers/coordinators who initiate the Archiving of Clinical Trial Master File (TMF).

The archiving of paper and electronic records ensures the integrity and secure retention of relevant records that serve to demonstrate the compliance of IDDI with the standards of Good Clinical Practice and with all applicable regulatory requirements. Records cannot be considered to have been archived unless they have been handled by the Archivist.

Role

  • The CTAA works together with the Clinical Trial Associate, the Project Managers and Project Coordinators to ensure that each Trial Master File is up to date and ready for archiving.
  • The CTAA works together with the Director Project Management for coordinating the Archiving Planning and Priorities.

Key Responsibilities

  • Plan and coordinate meetings with Project Managers and Project Coordinators in order to determine which documents are required in order to Archive their trial.
  • Perform TMF Quality Control
  • Prepare study files to transmit to the Archivist
  • Update Archiving Project tracker

Experience

  • Experience in clinical trials and Good Clinical Practice
  • Working knowledge of Microsoft Word and Excel
  • Fluent written and oral English
  • Familiar with Trial Master File Structure and Essential Documents
  • Experience in archiving is a plus

Key Competencies

  • Able to work independently
  • Methodical and logical
  • Ability to solve problems and to motivate others
  • Good interpersonal skills
  • Organized with excellent administrative skills

Relationships

This position reports to: Director, Project Management

Our offer:

We offer a 6 month contract (extension expected) in an innovative, dynamic and future-oriented company with a strong international environment.

Join IDDI and contribute to the progress of clinical research! An inspiring and exciting career with international and challenging projects is waiting for you!

We are looking for motivated, passionate and enthusiastic team players to help our clients accelerate delivery of their drugs. You will work with a dynamic, knowledgeable and international team with extensive clinical trial experience.

Interested in this challenging position ?

Please send your CV and cover letter in English by email to: careersbelgium@iddi.com

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IDDI