About the job

The client is preparing the launch of an international randomized clinical trial (RCT) across Europe 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 on-site 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

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Responsibilities

About the job

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