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Executive Director, Centralized Monitoring and Quality Assurance

hace 2 meses


Sevilla, Sevilla, España Mygwork A tiempo completo
About the Role

As a key member of our team at Mygwork, we are seeking an experienced Executive Director to lead our Centralized Monitoring and Quality Assurance efforts. This is an exciting opportunity to join a dynamic organization and contribute to the development and delivery of Risk-Based Quality Management (RBQM) strategies and centralized monitoring objectives.

Key Responsibilities
  • Provide operational and strategic leadership for the development and delivery of RBQM strategies and centralized monitoring objectives.
  • Direct, lead, and manage a team to successfully complete CM deliverables in support of clients and studies.
  • Develop and manage client and partner relationships, mentoring and directing staff and management.
  • Drive risk assessment and define mitigations and proper monitoring strategy for critical data and processes.
  • Drive policy development and support implementation of broader goals by working across departments.
  • Supervise and coordinate centralized monitoring client risk and data strategy delivery.
  • Ensure the CM teams are provided with the necessary support and resources.
  • Manage staff and management, including interviewing, professional development, and performance management.
  • Lead internal and cross-functional initiatives, including process and tool development.
  • Contribute to future strategy and vision for CM and Clinical Operations.
Requirements
  • Knowledge of broad drug development process and expertise in cross-functional adoption of Risk-Based Quality Management.
  • Knowledge of industry regulatory and clinical standards such as ICH E6 & E8.
  • 15+ years of previous experience within Pharma or CRO organizations, providing the knowledge, skills, and abilities to perform the job.