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) (CSLs), as well as general administrative support to the Clinical Operations department. In exceptional cases providing agreed upon support to other departments within Development.

Responsibilities
  • 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 CSLs 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 CSL.
  • 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.
Profile


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.
Location
Antwerp region
Contact person

Lies Deboiserie

Personal profile
Attachments
PDF, DOC, DOCKX (5MB)
Contact details
Tim
Janssen
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
tim.janssen@fern-valley.com