klinisch administratief medewerker/ clinical study administrator in Diegem
This individual will provide support to the clinical study staff within the Depuy Synthes franchise.
Responsible for processing, tracking, and filling of study documents, and management of the Trial Master File within the clinical projects. In addition, administratively support clinical study staff as required.
Supports project managers within the assigned clinical studies.
Key job activities - Clinical study administrative tasks counting for 90% of job content:
- Under general supervision, accountable for the timely tracking of study essential documents and ensuring completeness of the Trial Master File for assigned clinical studies according to appropriate regulations, department guidelines, and work instructions.
- Preparation of the Investigator Site File
- Assist study staff and investigators to quickly and effectively resolve issues relating to Study Files (Trial Master File and Investigator Site FIle). Respond to problems and assists in implementing corrective and preventive actions.
- Assist in providing internal communication of important clinical data and events.
- supports ongoing use of CTMS.
- Assist in tracking of study activities as applicable and documents relating to such activities.
- Coordinate with clinical project managers/ leaders and site monitors for site concerns/issues.
- Provide safety documentation to other functional groups in support of safety committee meetings as requested (supporting role).
- May be involved in other tasks to support Clinical Operations and Operating Company as needed.
Other administrative tasks - 10% of job content:
- Know, understand, incorporate, and comply with all applicable laws and regulations relating to DePuy Synthes business activities and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.
- Device ordering/shipment/accountability,if required.
- Assists in shipment and tracking of site files & images, as applicable.
- Minimum Bachelor's degree in Life Sciences is required.
- Requires previous administrative support experience or equivalent for at least 1 year.
- Advanced knowledge of Ms Excel as well as other Ms Office Programs.
- Good communication skills in English
- Clinical/ medical background is a plus.
- Previous clinical research experience is a plus.