• Responsible for the Trial Master File and ensuring it is complete and audit ready.
• Study protocol and other essential document formatting and QC checks, submission package preparation and QC checks as needed.
• Responsible for study closure and archiving as assigned.
• Tracking clinical study spending versus budget, verifying and managing invoices.
• Manage site and vendor contract process, filing and tracking.
• Responsible for meeting organization as needed (e.g. investigator meetings).
• Coordinates the development, review and approval of SOPs and templates.
• Organization and filing of scientific publications.
Supports the study monitor as needed in preparation for site initiation, monitoring, closure visits and related activities.
- At least 1-2 years of experience in similar position :an understanding of the CTC role with applicable knowledge of the essential clinical trial documents.
- Fluent in English, proficient in French. Fluency in another language an advantage.
- MSc degree, preferably in Scientific/Life Science field.
- Attention to detail, excellent organization, communication and teamwork skills.