Clinical Safety Manager - United States
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We are looking for experienced a Clinical Safety Manager with proven Clinical and Safety experience specifically on medical device trials to coordinate and ensure safety reporting across all studies. Manage the safety-related activities on clinical projects and minimize possible risks. Manage Clinical Safety Associates.
- Set-up and execute safety tasks within clinical projects in compliance with all requirements;
- Be the liaison between all stakeholders (DSMB, CEC, CA, EC and Clients);
- Primary contact for all safety related aspects within the organization;
- Write, develop and maintain SOPs and workflows applicable for the Safety Department;
- Supervise event narratives creation to assure accuracy and completeness;
- Host and manage safety related meetings;
- Assess adequacy of safety procedures to ensure study Safety issues are identified;
- Functional management of the direct reports.
A Higher educational degree (BSc, MSc) in a medical or science-related field, pharmacy, nursing is required. Prerequisite of minimum 5 year clinical research experience of which two years in the medical device/drug safety/(pharmaco)vigilance related function. Additional in depth knowledge of applicable European and FDA regulations and guidelines. Basic medical knowledge and a strong awareness of ICH/GCP. You are fluent in English. We are looking a strong communication with great organizational skills.