Clinical Study Administrator

  • Location: DIEGEM
  • Type: Contracting
  • Job #19785

Will you be our new ambassador?

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to pass our team. 

Let's look together at your first challenge with us!

Clinical Study Administrator

In this role you will provide support to the clinical study staff within Clinical R&D, as well as foster strong, productive relationships with colleagues within the Clinical R&D Organization.

Location: Beerse

Scope of work:

  • Clinical Administration Tasks – (includes CTMS build and tracking, v-TMF build & upload)
  • Under general supervision, accountable for the timely tracking of study essential documents and ensuring completeness of data and documentation for assigned clinical studies according to appropriate regulations, departmental guidelines, and work instructions.
  • Creation/distribution of regulatory binders & the wet-ink signed documents binder
  • Assist study staff and investigators to quickly and effectively resolve issues relating to specific documentation.
  • Respond to problems and assists in implementing corrective and preventive actions.
  • Assist in providing internal communication of important clinical data and events.
  • Support ongoing use of CTMS by maintaining and tracking relevant activities.
  • Provide safety documentation to other functional groups in support of safety committee meetings as requested (supporting role).
  • May be asked to provide support for study supplies creation, ordering and distribution to the sites e.g. print protocols, burn DVDs
  • May be asked to assist with device tracking and ordering if required and if applicable.
  • Assistance with logistics for Investigator meetings/expert panel meetings
  • Assistance with distribution of clinical updates newsletter
  • Participates in process improvement activities related to CTMS/vTMF within the department.
  • May provide other administrative support for clinical study or departmental activities as needed and assigned by supervisor or study leaders

Who are you?

Must

  • You have a bachelor’s or equivalent amount of experience
  • You have at least 1 year of previous administrative support experience
  • You have knowledge of Excel, Word and Power Point
  • You are fluent in written and spoken Dutch and English
  • You are well-organized
  • You pay attention to details

Plus

  • Previous Clinical Research experience is a plus
  • You have at least 1 year of previous administrative support experience
  • Experience tracking client issues is a plus

 

What can Jefferson Wells do for you?

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education. 

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