Associate Director - TMF Operations and Clinical Operations Analytics

The Associate Director is a vital member of the Clinical Operations Leadership Team in the Clinical Science and Medical Affairs organization. This role provides strategic leadership and oversight of Trial Master File (TMF) operations, enhancing functionality, efficiency, scalability, and quality. It also oversees Clinical Operations reporting, metrics, KPIs, and analytics.

Day-to-day involves serving as primary point of contact for TMF processes, systems, and study-specific support. Develop and oversee global TMF standards, SOPs, and controlled documents aligned with ICH-GCP, EMA, MHRA, and CDISC TMF Reference Model. Ensure inspection readiness and support audits and regulatory inspections.

Collaborate with senior leaders and stakeholders to establish, manage, and generate reports and analytics for performance measurement and optimization. Lead interpretation of metrics, communicate KPIs to teams and management, identifying trends and opportunities. Drive evolution of TMF support model and vendor relationships.

Work within a leadership environment with staff oversight responsibilities, potentially including line management. Lead governance with TMF vendors and represent TMF in system integrations like CTMS, EDMS, ISF, CDMS/EDC. Focus on continuous improvement in operations and analytics.