Clinical Study Associate - Mechelen, BE

Job description

Pleased to meet you, we are Galapagos, a dynamic fast growing Biotech company with offices in Europe in Belgium (Mechelen), France (Romainville), the Netherlands (Leiden), Switzerland (Basel) and in US, Boston.

We’re in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We want to challenge the impossible. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you: The ‘make-it-happeners’.

For our headquarter in Mechelen we are looking for a Clinical Study Associate.

Scope of the job

As a Clinical Study Associate you provide operational support to phase I to III clinical trials under the leadership of the assigned Clinical Study Leader(s) and in compliance with ICH-GCP (Good Clinical Practice) and relevant Standard Operating Procedures. And you provide general administrative support to the Clinical Operations department.

Your role

You will be involved in activities supporting Clinical Study Leaders/Clinical Compound Program Leaders regarding study set up, maintenance and closeout, which usually includes:

  • Providing support in the set-up of study/program specific meetings with internal as well as external members
  • Participation in relevant study/program related meetings ensuring finalization and distribution of meeting minutes
  • Assisting the CSL with the CRO selection process
  • Creation, review, maintenance and tracking of clinical trial documentation
  • Supporting the collection of sponsor specific submission documents making sure these are legalized, signed and notarized as applicable and in a timely fashion to meet submission timelines
  • Supporting the set-up of Investigator Meetings in collaboration with the meeting planner
  • Ensuring set-up and maintenance of study related databases and tracking tools as required throughout the trial
  • Creating and maintaining relevant study related contact lists
  • Sending out Study Newsletters / Study Correspondence to all participating sites and team members / sites as agreed within the study team Conducting initial review and tracking of invoices and vendor payments

Job requirements

Who are you ?

  • You have obtained a Bachelor’s degree in a scientific or administrative discipline.
  • A strong personality, a high degree of flexibility, assertiveness and excellent communication skills are essential.
  • A minimum of 1 year in a similar role is highly recommended.

What’s in it for you ?

You will be part of a fast growing and amazing company. As ‘make-it-happener’ you will get all the support you need to make your job successful. At Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organizational skills. Our employees are the strength behind Galapagos, a highly motivated team, eager to maintain Galapagos’ leading position and achieve breakthroughs in pharmaceutical research. Galapagos offers a competitive remuneration package and a dynamic work environment.

We are Galapagos : together we can make it happen…!