Clinical Science Manager

Job Summary

A company is looking for a Manager, Clinical Science.

Key Responsibilities:

• Independently plans and executes clinical studies and leads cross-functional teams responsible for the planning, execution, analysis and reporting of assigned clinical performance studies
• Evaluates and statistically analyzes data to confirm or deny performance claims supporting regulatory submissions and to ensure that the product conforms to defined user needs and/or requirements
• Identifies, qualifies, selects and manages external service providers responsible for multi-million dollar budgets

Required Qualifications:

• Bachelor of Science required in medical, biological, or closely related science or medical specialty
• Minimum 7 years of direct clinical study experience, of which a minimum of 2 years must include clinical study design responsibility
• Minimum of 2 years of IVD clinical study experience including the proven ability to oversee clinical teams in the conduct and report of multicenter, complex studies is required
• At least 2 years of demonstrated individual/team supervisory and management experience is required
• Must be able to work both independently and within a cross-functional team environment