Clinical Safety Specialist II
4 weeks ago
Shockwave Medical is a leading medical device company revolutionizing the treatment of advanced cardiovascular disease. We are seeking a highly skilled Clinical Safety Specialist II to join our team.
The Clinical Safety Specialist II will be responsible for ensuring the safe and effective use of our medical devices. This includes collecting and managing adverse event reports, collaborating with investigative sites and Contract Research Organizations (CROs), and ensuring compliance with regulatory requirements.
The ideal candidate will have a strong background in clinical research, with experience in adverse event management and medical device regulations. They will possess excellent communication and organizational skills, with the ability to work independently and as part of a team.
Key Responsibilities:
- Collect and manage adverse event reports
- Collaborate with investigative sites and CROs
- Ensure compliance with regulatory requirements
- Assist with preparation for Clinical Events Committee (CEC) meetings and Data Safety Monitoring Board (DSMB) meetings
- Perform and/or assist Data Management with database reconciliations
- Ensure quality and accuracy of site-reported safety information
Requirements:
- RN or equivalent healthcare experience with a life-sciences Bachelor's degree preferred
- Minimum 2+ years' experience of clinical research experience
- Experience including clinical safety adverse events management, cardiovascular disease and medical device clinical studies is preferred
- Strong written, oral, and interpersonal communication skills
- Proficient computer skills (Microsoft Word, Excel, PowerPoint, etc.)
- Good prioritization and organizational skills
- High attention to detail and degree of accuracy
Benefits:
- Competitive total compensation package
- Medical, Dental, Vision, Pre-tax and Roth 401k options with a fully vested match
- Short-Term and Long-Term Disability, and Life Insurance
- Employer contribution toward Health Savings Account (HSA)
- Competitive PTO balance
Perks:
- Calm App
- Pet Insurance
- Student Loan Refinancing
- Spot Bonus awards
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