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(Junior) Clinical Trial Assistant (NL/EN or FR/EN or NL/FR/EN)

  • Location:


  • Contact:

    Charlotte Evens

  • Job type:


  • Contact phone:

    +32 15 284 043

  • Industry:

    Life Sciences, Biotechnology

  • Contact email:

Do you actively want to contribute supporting drug development in one of the biggest biotech companies with an amazing pipeline? Then this is the job for you!

Job Description

As a Clinical Trial Assistant (NL/EN or FR/EN or NL/FR/EN) you will provide support for all study-related activities.


  • Supports the execution of clinical studies
  • Responsible for study start up activities
  • Tracks study related documents
  • Manages logistics and document exchange between clinical sites and our company
  • Actively contributes to results oriented department goals
  • Drives continuous improvement of GSO
  • Identifies opportunities and best practices with local and regional partners that will contribute to overall operational effectiveness
  • Updates Clinical Study Management Systems

Key Activities:

  • Responsible for study start up activities, including creating site folders, collating, preparing and maintaining eSIP documents, updating systems
  • Tracks and maintains adequate study related supplies in the office and facilitate their distribution to sites, including preparing and distributing Study File Binders and Site Initiation presentations/materials
  • Ensures collection, review, track and provision of appropriate clinical documents to support regulatory and EC/IRB submissions
  • Coordinates the preparation of the submissions and local tracking of applications and submission of IND safety reports to IRB/IEC as applicable and to central Research Ethics Boards (Canada & US)
  • Processes, reconciles, distributes and tracks essential documents and submits them to the archive in compliance with the company SOPs
  • Orders, processes and tracks Case Report Forms (CRF) and Patient Reported Outcomes (PRO)
  • Participates in organizing Investigator meetings and monitor workshops as required
  • Coordinates entry and maintenance of local data into study management systems
  • Completes tracking documentation as applicable, including but not limited to, spreadsheets and study trackers
  • Provides study administrative support to the country study team (Project Manager, Contract Manager, CRA) as required, including generation of study status reports
  • Provides support to responding to local audits and inspections
  • If required, set-up/maintains Courier Accounts and organizes sample shipments
  • Develops and maintains as appropriate to their role an effective relationship with local Regulatory Affairs to ensure consistent working practices for EC/IRB & Regulatory submissions
  • Participates in Local Study Team Meetings
  • Prepares draft Informed Consent Form for Project Manager review if applicable
  • Participates in GSO workshops and local study meetings, gives updates and take minutes as required
  • Supports the feasibility process as required
  • Supports any activities related to Centralized Monitoring as required
  • Coordinates translation of documents when required
  • If required, performs the Data Steward role
  • If required, performs a buddy/mentor role for new CTAs


  • Bachelor in the life sciences.
  • Work experience in life sciences or medically related field, including biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company. Previous experience as CTA is a plus.
  • Language skills: Very good knowledge of Dutch + English and/or French + English (mandatory)
  • Clinical trial process experience
  • Work involving data entry into systems/databases and/or business support
  • Attention to detail
  • Time management & prioritization
  • Flexibility
  • Relationship management
  • Organizational Skills
  • Written and oral communication skills
  • Good working knowledge of common software packages
  • Data analysis and presentation
  • Problem solver
  • Teamwork
  • Project Management (organization and prioritization)
  • Existing right to work in Europe


  • A balanced salary package based on your capabilities and experience.

Vacancy number: 18699