Denver , CO , United States Will be responsible for strategic planning design implementation and execution of clinical programs as well as interpretation of clinical study results preparation of study summaries and reports for regulatory filings presentations and publications for the Respiratory Division. • Demonstrate advanced comprehensive knowledge of clinical and laboratory study design and principals. • Demonstrate advanced comprehensive understanding of applicable Federal regulations Good Clinical Practices and international standards. • Provide effective leadership/champion interests of the Clinical Affairs Department as a whole. • Establish direction for Clinical Affairs department including clinical laboratories clinical research field research and coordination of clinical studies. • Develop SOPs and guidelines to assure internal files site files and field data conform to Good Clinical Practice regulation and appropriate sections of 21 CFR. • Identify clinical training needs and develop training materials for in-house and clinical site use. • Assist in contractual negotiations for all clinical studies involving outside parties. • Provide resources and oversight to any non-human clinical studies as necessary. • Provide interface with FDA on clinical matters including satisfying IDE • Develop and review clinical study protocols and obtain IRB approvals. • Develop and manage departmental budgets. • Demonstrate advanced oral and written communication skills.
REQUIREMENTS: - 5+ years working in a clinical environment and conducting clinical studies - 5+ years working in the medical device industry in a management capacity - Alternatively an advanced degree with 5 years of related clinical experience and 3 years of medical device industry experience in management will be considered - Demonstrate advanced comprehensive knowledge of clinical and laboratory study design and principles - Demonstrate advanced comprehensive understanding of applicable Federal regulations Good Clinical Practices and international standards - Demonstrate advanced oral and written communication skills. All inquiries and resumes will be kept in strictest confidence.
• EDUCATION: Bachelor’s degree in a clinical discipline (B.S.N etc.)