This is a long term opportunity (6 months of consultancy followed by a permanent contract within the client).
As a Clinical Trial Assistant (CTA) you are part of a clinical trial team and responsible for the administrative support during the startup, execution and closing of clinical studies. You have a wide variety of tasks and responsibilities.
As a key person you are essential for the smooth flow of the clinical trial process.
- You are accountable for the timely tracking of essential documents and ensuring completeness of the trial master file (TMF) for assigned clinical studies, according to appropriate regulations and guidelines
- You are responsible for the administrative support and corresponding towards the study site team
- You are responsible for the regulatory submission dossiers to CA and EC.
- You occasionally provide safety documentations to other functional groups in support of the Drug safety departement
- You set up and maintain study site files and binders
- You track the study activities in CTMS
- You liaise with study sites and establish good communication lines with various departments.
- You assist in site visits if required.
- You organize and review translations of study documents.
- You coordinate and follow up site payments
- You are the single point of contact between clinical study team and project manager
- You have a bachelor degree with a minimum of 2 years of experience as a CTA
- You are fluent in French and in English – speaking and writing
- You are a team player and have excellent communication skills
- You have advanced computer skills
- You are meticulous and efficient
- You are stress resistant and are able to take responsibility