- Minimum of a Bachelor’s Degree, preferably in a related science (e.g. Nursing, Health Sciences, Health Policy, Medical Technology, etc.).
- 5+ years of relevant clinical research experience
- Knowledge and Skills in medical device and IVD industry, GCP and new product development
- Working knowledge and experience with GCP and successfully applying this knowledge in the support, oversight and management execution of the planning, running and closure of clinical studies required.
- Established and proven ability to adequately review, interpret, apply in a compliant manner and educate stakeholders on applicable acts, laws, regulations, policies, and guidances governing clinical studies or trials required.
- Excellent communication skills: written, verbal and presentation skills required
- Working knowledge and application of ISO 13485, 21CFR820, 21CFR11, etc.
- Strong problem solving and analysis skills
- Strong teamwork and interpersonal skills
- PC skills to include Microsoft Office (Excel, Access, Word and PowerPoint)
- Established and proven experience and ability to interact in a professional manner with external stakeholders such as customers, patients and regulators
- Able to differentiate between conflicting priorities and issues to identify underlying causes
- Demonstrated ability to manage multiple tasks and assess priorities effectively
- Must have ability to accommodate approximately 60% travel
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