Senior Clinical Program Manager

Responsibilities

• Integrate with R&D during product development for new device indications
• Partner with Regulatory, Marketing, and R&D to design pre-market feasibility and pivotal clinical studies
• Collect clinical safety and performance data to meet regulatory requirements
• Work with key stakeholders to ensure appropriate data elements are captured during CRF development
• Assist in internal and external audits

Requirements

• Bachelor’s degree required
• Minimum of 5 years’ medical device clinical study experience
• Knowledge of, and experience with, the FDA and the EU regulatory environments
• Excellent written and verbal communication skills
• Strong analytical, critical thinking, and problem-solving skills
• Ability to participate in high-level technological and clinical discussions
• Proficient in Microsoft Office, Word, and Power Point

Benefits

• health insurance
• dental insurance
• vision insurance
• life insurance
• short-term disability insurance
• long-term disability insurance
• 401(k)
• paid time off
• more