" Are you an experienced Clinical Trial Assistant / Study Start-up Support Specialist? You work independently and are fluent in English & in French? Have you ever been responsible for the administrative support and corresponding towards the study site team, also for the regulatory submission dossiers to CA and EC? Then we have your dream job!"
For one of our clients located in the Walloon Brabant, we are looking for an Experienced Clinical Trial Assistant / Study Start-up Support Specialist (FR/ENG).
This is a long term opportunity (minimum of 12 months of consultancy followed by a permanent contract at the client).
As an experienced Clinical Trial Assistant / Study Start-up Support Specialist you are part of a clinical trials and regulatory affairs teams 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 department
- 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 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 2-3 years of experience as a CTA / Study Start-up Support Specialist
- You are fluent in English - speaking and writing (French is a big asset)
- You are a team player but work independently 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
- A balanced salary package based on your capabilities and experience, including extra legal benefits.
- Full-time position
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number: 17976