Clinical Operations Manager

2 weeks ago


California, United States Accordance Search Group Full time

POSITION: Principal authority for Clinical Operations - Medical Device sector

KEY RESPONSIBILITIES:

Oversee the strategy and implementation of clinical trials:

• Formulation of study protocols

• Management and presentation of data

• Creation of surgical methodologies

Supervision of:

• Research sites involved in the study

• External vendors

• Clinical and Regulatory advisors

Development of external partnerships:

• Clinics

• Healthcare professionals within the therapeutic area

Enhancement of departmental functions

Establish, refine, and oversee operational procedures

Lead, educate, and guide team members and consultants

Collaborate across various departments including R&D, Operations, Quality Assurance, and Regulatory Affairs

Essential Qualifications:

  • Extensive experience in US Investigational Device Exemption (IDE) trials, with a strong background in pivotal trials being advantageous
  • Proven track record with multiple medical devices, not limited to a single product
  • Familiarity with device submission processes
  • Onsite presence required 2-3 days per week


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