Associate Director, Global Monitoring Operations
Reports to: Sr. Director, Global Monitoring Operations
Location: Remote-based (US)
Position Overview:
The Associate Director (AD), Global Monitoring Operations is responsible for monitoring execution and quality oversight for insourced and CRO outsourced studies at Company. The AD, Global Monitoring Operations 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 AD, Global Monitoring Operations will support the development of process and practices within the Monitoring Operations function.
Responsibilities:
In collaboration with Clinical Trial Management, initiate a study monitoring strategy and oversight plan and ensure that the 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 to assess completeness and accuracy of site monitoring activities.
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.
Represent Monitoring Operations in cross-functional meetings and initiatives as a subject matter expert.
Requirements:
Education and/or Experience