We are a small, private, and well funded (venture backed) medical device company launching our first product. The Manager of Clinical Affairs will be responsible for the management, direction and strategic development of clinical studies in support of Company goals and objectives. This position reports directly to the Chief Medical Officer.
• Responsible for the overall management of the Clinical Affairs Department.
• Function as key contact person for all issues related to on-going or proposed clinical studies, or the resources required to support such studies.
• Develop business relationships with clinical investigators and their staff.Essential Duties and Responsibilities:
• Responsible for all activities related to the Clinical Affairs department, including budgeting, resource allocation, hiring and training of subordinate personnel.
• Responsible for meeting with physician investigators and hospital personnel to facilitate the training and implementation of all clinical protocols.
• Develops ongoing physician relationships that will facilitate an open and dynamic communication process that will aid the company in understanding customer observations and critical feedback for ongoing improvement
• Proactively looks for opportunities to improve our products efficacy through field observations and customer feedback.
• Responsible for ensuring that all on-going or proposed studies adhere to the appropriate legal, ethical and corporate requirements, including adherence to GCP/ICH/GLP.
• Responsible for the completion of and reporting on clinical studies used to support regulatory filings related to the Company’s products. Responsible for the submission and support of trials used to support market clearance for the Company’s products.
• Responsible for the maintenance and accuracy of all records pertaining to on-going clinical studies. Ensures that all retained records comply with relevant legal and corporate requirements.
• Maintains ethical standards consistent with the companies values and FDA and SEC guidelines
• Ensure that all approved studies are provided with the resources required for successful execution.
• Responsible for defining the requirements and duties of clinical data manager, clinical data entry personnel, clinical research associate, and consulting services (including statistician, database, etc.)
• Serve as representative of Clinical Affairs for project teams and as primary contact for internal departments. Specifically, support of sales and marketing teams related to clinical results education and preparation of labeling materials.
Requirements:
Degree: BS/BA degree in related scientific discipline. MS preferred.
Experience: Preferred 5 years experience in management of clinical affairs group in medical device company.
Language Skills: Excellent written and oral communication skills.
Computer Skills: Proficient with MS OFFICE.
Thorough understanding of Good Clinical Practices, ICH and applicable regulations regarding research and regulation of medical devices
Travel: up to 40%, primarily domestic
Interested candidates may send resumes and cover letters in the form of an attachment to clinicaljobs@barrx.com.
Please type your name and the name of the position in the subject line
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