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Director, Clinical Affairs (Cardiovascular)

Director, Clinical Affairs (Cardiovascular)

Job Title: Director, Clinical Affairs (Cardiovascular)
Contract Type: Permanent
Location: San Jose, California
Industry:
Salary: Negotiable
Reference: AM10010_1488573983
Contact Name: Amy Ma
Contact Email: a.ma@sciproglobal.com
Job Published: March 03, 2017 20:46

Job Description

Essential Functions:

  • Provide overall management for clinical trials as assigned
  • Manage all aspects of trial budgets, costs, and site payments
  • Originate clinical trial protocols and ancillary documents
  • Provide project/study management and monitoring plans for projects
  • Develop and maintain relationships with investigators, coordinators and site staff
  • Ensure conformance with GCP, ISO, MDD, CFR and other regulations as necessary
  • Investigate and solve problems that impact work processes and personnel in multiple departments
  • Ability to develop presentation materials and make presentations to senior staff
  • Assist with the planning, preparation and presentations at Investigator Meetings
  • Ability to multitask business, clinical, product and physician requirements

Education/Experience:

  • BS degree in life sciences plus 10 years of related work experience, MD or PhD preferred
  • Experience developing and executing clinical programs for medical devices, including prior clinical trial project management
  • Prefer MD orPhD. Minimum requirement: BS degree in life sciences plus 10 years of related work experience, or equivalent combination of education and experience
  • Prior people management and clinical trial project management experience required
  • Fluent in both written and spoken English