Posted 3 years ago
We are actively seeking a dynamic professional for a promising opportunity as Clinical Project Manager, will be responsible for working cross-functionally to develop the Clinical Strategy Plans to develop and conduct clinical research initiatives.
Job Description
- Comprehensive study management for Post-Market clinical initiatives
- Ensure all research programs are conducted in accordance to approved project plan, compliance to company standard operating procedures.
- Manage Study Approval process and provide Study Status Reports through monthly meetings with various cross-functional Leadership teams
- Attending meetings to present data and develop partnerships
- Quality Assurance support and management level representation during audits and inspections
- As required to perform other clinical duties as well.
Required Skills
- Bachelor’s degree in Science, Engineering, or related medical/scientific field
- 10+ years of medical device clinical research experience
- Experience in conducting Pre- / Post-Market Clinical strategies to align with business objectives; experience in Class II and III medical devices
- Experience working with physicians within the Peripheral, Cardiovascular, and Neurovascular therapeutic environment
- Experience with site and sponsor level FDA BIMO investigation(s)
- Experience collaborating with Marketing, Sales, Professional and Clinical Education (PACE), Medical Affairs, and Field Clinical to understand and develop Clinical Strategy Plans
- Experience in data management, safety surveillance, Market Access, and Medical Writing