The client is preparing the launch of an international randomized clinical trial (RCT) across Europe Canada, and the United States to support marketing authorization. Due to the absence of a full CRO model, key activities will be managed internally. We are therefore seeking experienced Senior CRAs to support site selection and regulatory submissions.

Scope of the mission - – Site selection (including in office visits if required) - – Support to site onboarding and informed consent preparation - – Package preparation for Regulatory submissions (Ethics Committees / Competent Authorities) - – Adaptation of documents to local requirements and translation coordination - – Country-specific regulatory guidance Profile requirements - – Senior CRA with strong autonomy - – Experience in site selection and submissions - – Knowledge of local regulatory requirements - – Late-stage study experience (phase II, III) - – Solid understanding of country-specific regulatory frameworks - – Local language may be required depending on country

📌 Senior Clinical Research Associate (Saguenay)
🏢 Bilinguallink
📍 Saguenay