Your responsibilities
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
1.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.
- Development of TMF Plan in collaboration with Clinical Project Manager (CPM). o Set-up, maintenance, close-out and archiving of Sponsor TMF.
- Ongoing filing of documents and maintenance of related TMF inventory
- Assist the CPM with periodic reviews of the Sponsor TMF, including outsourced sections, as needed.
- 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.
2. Administrative support to Clinical Operations Team, including but not limited to:
- Assistance with the planning and preparation of internal and external meetings, including preparation of minutes and on-site support of Investigators Meetings.
- Formatting of clinical trial documents / manuals and arranging their translations.
- Assistance with preparation and distribution of Newsletters / Site Correspondence. Creation and maintenance of the study contact lists.
- 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.
- Preparation, handling, distribution and tracking of Clinical Trial Supplies
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 multitasks environment