Care Manager providing case management services in Critical Time Intervention program for adults with behavioral health needs. Collaborating with multidisciplinary team to deliver person - centered care plans.
About the role
- Senior Manager in Clinical Science responsible for clinical studies and evaluations in medical affairs. Focusing on treatments for structural heart disease with a passion for improving patient lives.
Responsibilities
- Provide scientific expertise for clinical studies and evaluations in the TMTT division
- Independently author complex documents including clinical protocols and reports
- Conduct literature reviews from initiation to completion
- Review raw and summary clinical data for accuracy
- Analyze safety and effectiveness results from clinical trials
- Collaborate with cross-functional teams on study results
Requirements
- Bachelor's Degree in a related field with 10 years of related experience in clinical science or medical/scientific writing; OR Master's degree with 8 years of related experience; OR Doctorate degree with 8 years of related experience
- Familiarity with coronary interventional and/or structural heart environments
- Experience in the application of MEDDEV 2.7/1 and EU MDR for clinical evaluations
- Experience with FDA PMA applications
- Strong knowledge of scientific research methodology, GCP, ICH guidelines and Global regulations
- Experience in a cross-functional environment, collaborating with various specialists
- Excellent communication skills and experience influencing stakeholders
- Expert knowledge of regulatory requirements and clinical study execution
Benefits
- COVID Vaccination Requirement: proof of vaccination required for healthcare roles
- Equal Opportunity/Affirmative Action employer
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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