Clinical Manager II
6201 South Freeway Fort Worth, TX 76134 US
Job Description
Job Purpose:
Perform Medical Safety activities for assigned projects or products, primarily (but not limited to) supporting clinical study activities.
Job Functions: 1. Provide input for safety sections for study protocols, study reports, clinical overviews, and regulatory documentation pertaining to EU MDR post-market clinical follow-up activities. 2. Monitor the safety of assigned products/projects, including adverse events and patient impact from technical complaints (device deficiencies) from studies, literature, and post-market surveillance. 3. Compile, analyze, and interpret clinical and scientific data from multiple sources; summarize safety trends with supervisory guidance. 4. Support the preparation and maintenance of post-market surveillance plans, periodic safety updates, product labelling and related documents. 5. Perform medical review of single cases and/or aggregate data as needed. 6. Complies with all policies and standards.
Minimum Education:
Bachelors Degree or Equivalent years of directly related experience in ophthalmic clinical research or safety surveillance.
Preferred Education:
Advanced Degree (MD or OD) is strongly preferred but essential for performing medical review. Master of Science or health-related discipline is considered, and the preferred discipline is contingent on the assigned therapeutic area(s).
Minimum Work Experience: 3 years of relevant experience
Preferred Work Experience: 2 years of industry experience in product development, such as medical safety, clinical research, or regulatory affairs.
Language Skills:
The ability to fluently read, write, understand and communicate in English.
Target pay: 70-71/hr
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