Clinical Manager II
6201 South Freeway Fort Worth, TX 76134 US
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.
Bachelors Degree or Equivalent years of directly related experience in ophthalmic clinical research or safety surveillance.
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.
The ability to fluently read, write, understand and communicate in English.
Target pay: 70-71/hr
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.