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
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