Associate Director - TMF Operations and Clinical Operations Analytics

The Associate Director of Strategic TMF Operations and Clinical Operations Analytics serves as a vital member of the Clinical Operations Leadership Team in the Clinical Science and Medical Affairs organization. This role delivers strategic leadership and oversight for Trial Master File (TMF) operations to boost functionality, efficiency, scalability, and quality. The ideal candidate brings TMF system expertise, vendor oversight, and inspection readiness skills.

Day-to-day involves managing TMF vendors, developing global standards and SOPs aligned with ICH-GCP, EMA, MHRA regulations, and CDISC best practices. Responsibilities include reviewing clinical documents like study plans and generating TMF metrics for leadership. The role also covers leading budget negotiations and governance with TMF vendors.

In Clinical Operations Reporting and Analytics, create sophisticated metrics, KPIs, and reports to measure performance and compliance. Collaborate with senior leaders to interpret trends, communicate insights to teams and management, and ensure scalable solutions. Drive assessments of supporting systems for risk management and data alignment.

This position offers staff oversight and potential line management within a collaborative leadership environment. Opportunities include continuous evolution of TMF models and analytics strategies for organizational improvement. Engage with stakeholders across systems like CTMS, EDMS, and CDMS for integrated operations.