Clinical Study Assistant with people management skills! - 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 (Bazel) 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’. 

 

We are looking for a Clinical Study Assistant with people management skills

                                               

Scope of the job

 

As a Clinical Study Assistant (CSA) you manage a team of CSA's and provide operational support to phase I to III clinical trials in compliance with ICH-GCP (Good Clinical Practice) and relevant Standard Operating Procedures. You will also 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
  • Attending relevant study/program related meetings ensuring finalization and distribution of meeting minutes
  • Supporting the collection of sponsor specific clinical study submission documents making sure these are legalized, signed and notarized as applicable and in a timely fashion to meet submission timelines
  • Supporting CSLs in proper TMF management, review (i.e. Quality checks delegated to CSAs) and archiving (coordination, consolidation of TMF documents).
  • Supporting the organization of Investigator Meetings in collaboration with the contracted meeting planner
  • Creating and maintaining appropriate tools or trackers as required for agreed study related activities (for example collection of signatures for submission documents, requesting insurance certificates, follow-up on information needed for the activation of sites etc.).
  • Ensuring set-up and maintenance of clinical study databases/systems throughout the study, as required
  • Creating and maintaining relevant study related contact lists  
  • Distribution of Study Newsletters/ Correspondence to study related contacts Providing support in the set-up of departmental and cross-departmental meetings including the creation, finalization and distribution of meeting minutes.
  • Support the review and tracking of invoices and vendor payments

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. 
  • You are competent in team leadership and team facilitation.
  • You have a minimum of 5 years’ experience in a similar role within clinical development.

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…!