Associate Director - TMF Operations and Clinical Operations Analytics

1w1 week ago

TransPerfect

Full-time · $200,000 – $280,000

About this role

The Associate Director of Strategic TMF Operations and Clinical Operations Analytics serves as a vital member of the Clinical Operations Leadership Team. This role delivers strategic leadership and oversight for Trial Master File (TMF) operations, boosting functionality, efficiency, scalability, and quality. Expertise in TMF systems, processes, vendor oversight, and inspection readiness is essential.

Day-to-day involves managing TMF vendors, developing global standards and SOPs aligned with ICH-GCP, EMA, MHRA, and CDISC best practices. Lead inspection readiness, audit support, and review of clinical documents like study plans. Generate and present TMF metrics and KPIs to leadership.

Oversee Clinical Operations reporting, metrics, KPIs, and analytics in collaboration with senior leaders and stakeholders. Create sophisticated reports to measure performance, compliance, and effectiveness. Interpret trends and communicate insights to study teams and management.

Drive continuous improvement of TMF support models, vendor relationships, and analytics systems. Ensure alignment across interfacing systems like CTMS, EDMS, and CDMS/EDC. Provide staff oversight and participate in governance committees.

Requirements

TMF system and process expertise
Exceptional vendor oversight and management
Strong foundation in inspection readiness and regulatory support
Knowledge of ICH-GCP, EMA, MHRA regulations, and CDISC Trial Master File Reference Model
Experience with systems interfacing with TMF such as CTMS, EDMS, ISF, CDMS/EDC
Proficiency in developing clinical operations metrics, KPIs, and analytics
Leadership in governance committees and vendor relationships
Supervisory experience with staff oversight

Responsibilities

Provide oversight and management of TMF vendors and associated processes
Develop and oversee global TMF-related standards, SOPs, and controlled documents aligned with ICH-GCP and industry best practices
Ensure inspection readiness and support audits and regulatory inspections
Develop, generate, analyze, and present TMF metrics/KPIs to demonstrate TMF health
Lead continuous evolution, implementation, and oversight of TMF support model
Manage TMF vendor budget negotiations and operations spend
Create and generate reporting, metrics/KPIs, and analytics for Clinical Operations performance
Communicate performance metrics and KPIs to study teams, functional leadership, and senior management