Global Operations Director

3 weeks ago

South San Francisco, California, United States Clinical Dynamix Full time

Job Title: Associate Director, Global Monitoring Operations

Reports to: Sr. Director, Global Monitoring Operations

Location: Remote-based (US)

The Associate Director, Global Monitoring Operations is responsible for monitoring execution and quality oversight for insourced and CRO outsourced studies at Clinical Dynamix.

This role will also be responsible for management of assigned Company CRAs to optimize productivity and ensure quality, efficient end-to-end delivery of Monitoring Operations.

The Associate Director, Global Monitoring Operations will support the development of process and practices within the Monitoring Operations function.

Key Responsibilities:

  • Collaborate with Clinical Trial Management to initiate a study monitoring strategy and oversight plan.
  • Ensure monitoring activities for each assigned study/region are compliant with the Clinical Monitoring Plan.
  • Author or review Clinical Monitoring Plan.
  • Participate in site feasibility, qualification, and selection.
  • Conduct or arrange for monitoring oversight visits (MOV) for CRO, and CRA assessment visits for Company CRAs.
  • Proactively identify issues at a study, site or CRA level, and ensure resolution of issues, identification of areas of risk and mitigation strategies.
  • Document and track performance indicators and metrics for trends and to assess CRO and/or Company CRA progress, quality, Clinical Monitoring Plan compliance and overall performance.
  • Review Monitoring Visit Reports from CRO and/or Company CRAs and escalate monitoring visit trends or findings to Clinical Operations study leads.
  • Track status of reports, action items, and corrective/preventative actions identified for sites and/or monitoring performance.
  • Training and support for the CRO and/or Company CRA team on monitoring aspects of the study in partnership with other team members as needed.
  • Act as a point of escalation for resolution of site performance, quality or compliance problems.
  • Attend CRO oversight or extended study team meetings.
  • Maintain strong relationship with CROs and investigator sites.
  • Represent and provide input into evaluation of monitoring services in the CRO proposal process and offer recommendations for CRO selection.
  • Lead or provide input into monitoring and/or other functional area processes and forms.
  • May be responsible for direct management of assigned FTE CRAs, including routine performance feedback/assessment, resourcing, coaching, training, career development, and corrective action plans.
  • Oversee Functional Service Provider (FSP) or Contract CRAs if used within Company.
  • Lead or participate in interviewing, hiring, onboarding, and orientation processes for Company CRAs.
  • Review proposed CRO CRA staff against established qualifications and document outcome.
  • Support CRAs, project team, and Quality Assurance with responses to audits or inspections.

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