YOUR RESPONSABILITIES
Administrative support including but not exclusive
PRIMARY ROLE
Trial Master File management and administrative support, in compliance with SOPs, ICH guidelines (including
GCP) and all other EU/US legislations and directives relating to clinical research activities.
NATURE AND SCOPE OF RESPONSIBILITIES
- Administrative support to Clinical Operations Team, including but not limited to: o Assistance with the
planning and preparation of internal and external meetings, including preparation of minutes and on-site
support of Investigators Meetings.
o Formatting of clinical trial documents / manuals and arranging their translations.
o Assistance with preparation and distribution of Newsletters / Site Correspondence. Creation and
maintenance of the study contact lists.
o Data entry into designated clinical tracking systems in accordance with project requirements o
Assistance with regulatory submissions / notifications, as needed, including but not limited to support
with the preparation of Ethics Committee submissions, compiling the required documents, uploading of
files on CTIS or other required platforms.
o Preparation, handling, distribution and tracking of Clinical Trial Supplies - Trial Master File (TMF) management from study start-up to close-out, ensuring all essential documents and
relevant correspondence are filled in a timely manner.
o Development of TMF Plan in collaboration with Clinical Project Manager (CPM). o Set-up, maintenance,
close-out and archiving of Sponsor TMF.
o Ongoing filing of documents and maintenance of related TMF inventory
o Assist the CPM with periodic reviews of the Sponsor TMF, including outsourced sections, as needed.
o Preparation and distribution of the Investigator Site Files. o Tracking of filed documents in Sponsor TMF
and Investigators Site Files (ISF), and proactive alerting the CPM or CRA, as appropriate, on missing
documents.
YOUR PROFILE
- Bachelor degree in administration / secretary; heath related degree is a plus
- Prior experience as Clinical Trial Assistant
- Familiar with ICH-GCP and Documentation management
- Excellent English knowledge (written, spoken, understanding), French and Dutch are a plus.
- Excellent Computer Skills
- Excellent organizational and communication skills (hands-on personality)
- Flexibility to operate in multitask environment