Clinical Project Manager - Medical Device  (Job ID 169 CPM)
Chicago, IL

The Clinical Project Manager will work collaboratively with the Medical Director to support a portfolio of new product development and product support projects, acting as a clinical resource for new products and therapies to sales, product development and marketing. Part of your responsibility will include include presenting this information at various meetings and professional education seminars.  This individual will also support the Clinical Affairs organization in developing and improving Standard Procedures and reporting process and forms.

Primary Responsibilities:

• Manage clinical strategies and deliverables with the Medical Director for device and drug programs from concept to product launch
• Compliance with company and division policies and procedures, Regulatory Authority requirements and guidelines and ICH Guidelines in support of global business objectives
• Contribute to the Clinical Development Plan and clinical trial protocols
• Collaborate with a study manager to execute the clinical trials
• Responsible for the management of clinical deliverables required by the company’s product development process for both drug and device development programs
• Partner with the Medical Monitor and Regulatory Affairs to develop the clinical development strategies and prepare a clinical plan for each project
• Recognize and maintain strong business relationships with stakeholders and key opinion leaders
• Facilitate preparation of annual safety reports and other regulatory commitments
• Act as a clinical resource for new products and therapies to sales, product development and marketing. This may also include presenting this information at various seminars
• Assist in the orientation and training of new clinical research staff members

Education Requirements:

• Bachelors Degree in Science or a medical field

Position Requirements:

• 5+ years pharmaceutical or device clinical development experience
• Comprehensive knowledge and understanding of FDA regulations and ICH Guidelines for Good Clinical Practices
• Proficient in data collection design, scientific evaluation and clinical planning
• Demonstrated ability to represent Clinical Affairs in global project teams, execute clinical strategies and manage complex programs in a fast paced milestone focused environment
• Comprehensive understanding of the drug/device development process
• Solid technical basis in pharmaceutical development and delivery systems technologies
• Proven ability in planning and conducting clinical trials
• Experience with regulatory submission procedures, e.g. NDA, CTD
•  Protocol, Report and Investigator’s Brochure writing experience

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