Clinical Study Assistant

Job description

Providing operational support to phase I to III clinical studies under the leadership of the assigned Clinical Study Leader(s), as well as general administrative support to the Clinical Operations department. In exceptional cases providing agreed upon support to other departments within Development.

  • Build a sound relationship with the people they support, making sure their timely support can be guaranteed for those activities agreed upon.
  • Provide support in the set-up of study/program specific meetings with internal as well as external members.
  • Attend relevant study/program related meetings. For meetings hosted by the company’s staff, this includes ensuring finalization and distribution of meeting minutes.
  • Develop and maintain system related documents and training material (for example for CTMS or eTMF).
  • Set-up and maintenance of clinical study databases/systems throughout the study, as required.
  • Create and maintain 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.).
  • Support 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.
  • Support Clinical Study Leaders in proper TMF management, review (i.e. Quality checks delegated to CSAs) and archiving (coordination, consolidation of TMF documents).
  • Support the organization of Investigator Meetings in collaboration with the contracted meeting planner
  • Create and maintain relevant study related contact lists.
  • Distribute Study Newsletters/Correspondence to study related contacts as agreed upon by the Clinical Study Leader.
  • Support the review and tracking of invoices and vendor payments.
  • Maintain the departmental intranet on SharePoint.
  • Provide support in the set-up of departmental and cross-departmental meetings including the creation, finalization and distribution of meeting minutes.
  • Support the follow-up on Confidentiality Agreements.
  • Track IBs distributed by the study team.
  • Minimum of a Bachelor’s Degree is required
  • Requires previous experience in Clinical Research (3 years)
  • Knowledge of Good Clinical Practices (GCP)
  • Belgian residence required, since this vacancy is office based (2-3 days / week)
  • Demonstrated competencies/skills in the following areas are required:
  • Excellent written and verbal English communication skills, preferably also good knowledge of Dutch/French
  • Hands-on mentality, effective planning and organization skills
  • Computer skills (Microsoft office – Excel, Word and Power Point)
  • Attention to detail
  • Excellent follow through
Our offer
  • An attractive salary in line with your experience and skills.
  • Fringe benefits including a medical insurance, pension plan and a care plan.
  • A supporting environment.
  • Respect for the life-work balance.
  • Career planning.
  • A focus on professional and personal growth through training and coaching.
  • Room for personal engagement to help shape our company's future.
Contact person

Evelien Van Eecke:

Personal profile
Contact details
Managing Partner

Do you want to learn more about Fern Valley? Are you interested in seeing how we can help your company grow? Let's get acquainted. I'll be delighted to hear your story and to share our vision. Experience the personal & open approach of Fern Valley and embark on a journey with us.

+32 487 10 61 46