The Associate Clinical Director provides strategy and direction to execute interventional peripheral pre-market clinical studies. This position requires strong project management skills and proven clinical trial management experience. Specific responsibilities include: oversee management of multi-center global studies; give direction to clinical study staff on study execution including regulatory requirements, data management, contracts, statistical analysis, quality assurance, vendor management and budgets.
Summary of Position with General Responsibilities:
• Provide key protocol inputs to design, trial logistics and execution
• Development and management of detailed project plans
• Oversee selection process of internal and external experts and suppliers
• Prepare internal and external executive reports
• Hire and manage internal clinical trial support staff
• Assist in the negotiation process of site related contracts and negotiate supplier contracts
• Give direction for creation of all necessary study materials
• Ensure high study compliance and trial execution
• Ensure adherence to department and company SOPs
• Seek out and provide opportunities for continuous education
• 9 or more years experience in medical device industry; interventional cardiology, surgical, nephrology or interventional radiology site management experience highly preferred.
• Broad clinical trial management experience from start to end and demonstrated ability in closing trials effectively.
• Must have in-depth knowledge of IDE, PMA, 510(k) or equivalent and GCP/GLP procedures and understand FDA and IRB submission requirements.
• Demonstrated ability to lead data analysis and writing to support study reports.
• Ability to represent and effectively communicate peripheral clinical plans on cross-functional teams.
• Possess strong interpersonal and communication skills.
• Working knowledge of statistical concepts.
• Possess strong problem-solving and analytical skills.
• Contract negotiation experience required.
• Understand and interpret technical, scientific and clinical information as it applies to product approval activities.
• Demonstrated ability to lead teams to translate issues into actions, make decisions and influence outcomes.
• Ability to manage programs within budget.
Education and/or Experience:
• Bachelor’s degree in life science required; advanced degree in biological or medical/clinical sciences preferred.
While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment. The employee frequently is required to talk and hear.The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.
C. R. Bard - 2 years ago
C. R. Bard is no upstart in the world of medical devices. The company has been in the business for more than a century and introduced the...