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Clinical Safety Manager - United States  

GENAE (company)

Posted on : 10 April 2017

Project Description

Interested in joining a growing full-service Medical Device CRO, with global locations across the US, Europe and the Middle East? Build expertise and learn from your peers but more importantly, contribute to the success of some of the most innovating medical device trials in the industry.

Role Objective:
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.

Job Type: