Do you have a Scientific degree and would like to start your career in a dynamic medical device environment ? Don't hesitate and apply !
The Clinical Study Assistant will provide support to the clinical study staff within Clinical R&D, as well as fostering strong, productive relationships with colleagues within the Clinical R&D organization. Responsible for processing, tracking, and filing 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.
Clinical Administration Tasks 85% - (includes (one)CTMS build and tracking, v-TMF build & upload):
- 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, 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 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.
- Support ongoing use of (one)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 newsletter (create mailing list from (one)CTMS and routing for internal approval)
- Participates in process improvement activities related to (one)CTMS/vTMF within the department.
Other Administrative Tasks 15%:
- May provide other administrative support for clinical study or departmental activities as needed and assigned by supervisor or study leaders
- University Degree is required
- Previous clinical research experience (internship or working experience) or min1 year experience in an admin role within the pharma/medical device industry
- Fluency in English and Dutch or in English and French
- Experience and knowledge working with computer systems (Microsoft office - Excel, Word and Power Point).
- Soft skills : pay attention to details, organized
- Existing right to work in Europe is required
- A balanced salary package based on your capabilities and experience
- Full-time opportunity
- Hybrid working (50/50)
Vacancy number: 23428