For one of our clients, located in Mechelen, we are currently looking for a "Clinical Study Assistant".
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.
- 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 Client 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.
Do the above responsibilities fit you like a glove?
Upload your CV and motivation letter via the "apply now" button and you can expect feedback from us soon.
If something is not entirely clear, you can reach out to us by telephone off course.
- Former CSA experience
- Good knowledge of English and Dutch, French is an asset
- Good communication skills
- Pro-active attitude
- Good MS Office skills
- Able to multitask
- A balanced salary package based on your capabilities and experience.
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number: 16486