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Clinical Quality Assurance Manager (Human Clinical Trials)
Ref No.: 17-09715
Location: Culver City, California
Position Type:Contract to Hire
Experience Level: 6 Years
Clinical Quality Assurance Manager
Culver City, CA
Permanent

**experience auditing human cliniical trials REQUIRED** 
 
Responsibilities
  • Responsible for managing the GCP quality programs. We are seeking and individual who is adept at cross functional leadership including developing, leading and implementing quality processes across study phases (preclinical –phase IV)
  • Ensures GCP compliance by building and maintaining effective and compliant global quality systems
  • Conducts quality oversight of all study activities and provides risk mitigation strategies and process improvement feedback to project leaders and senior management
  • Promotes recognition of quality programs among internal and external colleagues and collaborators
  • Plans and conducts audits of clinical trial vendors including clinical study sites, analytical laboratories and Contract Research Organizations
  • Reviews external and internal documentation routinely to ensure completeness, consistency and adherence to applicable standardized operating procedures
  • Performs extensive quality reviews of monitoring reports, on-site activities and electronic data capture (EDC). Reviews and approves controlled clinical trial documentation
  • Confirms clinical trial study reports against source data for data accuracy, integrity and consistency
  • Prepare, train and monitor clinical sites for federal and international inspections and hosts regulatory agency audits of clinical trials
  • Supports the clinical operations and medical teams by providing input and oversight to GCP related activities
  • Works with vendors to ensure they meet or exceed quality obligations. Creates and maintains a list of approved clinical vendors
  • Recruits, trains and manages qualified staff within the clinical quality assurance department (if required)
 
Requirements: 
  • Travel - Travel may be required (up to 40%)
  • Minimum of a BS/BA in natural sciences or equivalent experience. Certified Quality Auditor Certification is a plus
  • At least 7 years of experience in positions of increasing responsibility in clinical quality assurance
  • Solid understanding of global ICH GCP requirements with the recent updates
  • Solid understanding of quality management systems and continuous process improvement principles including global ICH GCP requirements, and other relevant regulations and guidance to assure quality of clinical studies and compliance with relevant global regulations and guideline
  • Good written and oral communication skills
  • Demonstrated ability to work in a multi-disciplinary setting, acting as a creator and facilitator to drive fulfillment of corporate strategic goals
  • Core Competencies 
  • Strong scientific/technical skills
  • Strong interpersonal capabilities and ability to build and maintain networks
  • Ability to anticipate and resolve problems effectively
  • Strong verbal communication and technical writing skills
  • Ability to present clearly using scientific and clinical terminology
  • Strong interpersonal skills and the ability to communicate effectively with people in diverse and different settings
  • Possesses sense of urgency; identifies challenges and problems and takes the initiative to identify solutions
  • Motivates team members; fosters and nurtures teamwork