Clinical Operations Manager

1 week ago


Seattle, Washington, United States Precision Medicine Group Full time
Job Summary

The Clinical Operations Manager, Global Clinical Monitoring, is a key role within the Clinical Operations team at Precision Medicine Group. This position is responsible for managing and developing the organization's Clinical Research Associate (CRA) workforce, as well as supporting the development of departmental initiatives to strengthen the quality and productivity of Global Clinical Monitoring operations.

Key Responsibilities
  • Manage and develop a team of CRAs to ensure high-quality delivery of individual, team, and departmental goals.
  • Assist with and contribute to project resourcing to ensure proper level and allocation of resources are assigned for each project within their hierarchy.
  • Update tracking systems and interface with project teams.
  • Collaborate with the Clinical Team Leads/Clinical Trial Managers and Clinical Operations Management Team to ensure that resource needs and site requirements are met appropriately.
  • Develop, mentor, manage, and coach CRA staff to progress their skills so that Precision Medicine Group quality standards are maintained.
  • Advocate individual career development and individual responsibility/accountability.
  • Perform accompanied site visits to assess CRA skills and developmental needs, as well as assist CRAs with project-specific issues.
  • Identify quality risks and issues and recommend corrective action plans as needed to leadership team to address deficiencies in performance of employees.
  • Ensure that all staff have the proper resources, training, materials, and access to systems to deliver on the expectations of their position.
  • Ensure CRAs provide timely and accurate updates of all required administrative material (SOPs, T&E, etc.) on company systems.
  • Work with the Clinical Operations Management Team to continually improve and enhance CRA expectations and procedures to promote quality, consistency, and efficiency in execution.
  • Develop and maintain metrics pertinent to CRA resource oversight, and work with Clinical Operations Management Team on the evaluation of these metrics.
  • Participate in the interview process for new CRAs by conducting CV review and participating in the interviewing process.
  • Conduct on-boarding training for new CRA staff in conjunction with Human Resources, Clinical Training, and other functional areas.
  • Represent Precision Medicine Group in a professional manner.
  • Manage CRA staff in accordance with Precision Medicine Group's values and policies.
Qualifications
  • Minimum Required:
    • Graduate, postgraduate, 4-year college degree, or equivalent experience ideally in a scientific or healthcare discipline.
  • Other Required:
    • At least 7 years or more in clinical operations, data management, or related discipline either in CRO or Pharmaceutical industry with a minimum of 5 years onsite monitoring experience.
    • Monitoring experience includes use of electronic data capture systems as well as paper and electronic medical records.
    • 3-5 years of direct supervisory experience managing CRAs is expected in candidates for this position including:
      • Experience creating effective development programs for clinical staff.
      • Experience developing evaluation processes, performing gap analysis, and ensuring all clinical staff are properly trained to perform their duties consistent with Precision Medicine Group quality standards.

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