Associate Director, TMF Operations and Clinical Operations Analytics

Role Summary

Associate Director, TMF Operations and Clinical Operations Analytics provides strategic leadership and oversight of Trial Master File (TMF) operations and Clinical Operations reporting, metrics, and analytics. This role leads TMF system/process improvements, vendor oversight, and inspection readiness, while also delivering performance measurement and continuous improvement analytics to senior leadership.

Responsibilities

• TMF Operations: Accountable for the TMF support model, processes, and systems
• Responsible for oversight and management of TMF vendors and associated processes
• Primary point of contact related to TMF processes and study-specific TMF support
• Develop and oversee global TMF standards, SOPs, and controlled documents compliant with regulations and industry best practices
• Provide leadership to ensure inspection readiness and support for audits/regulatory inspections
• Review TMF operations input into clinical documents, particularly study plans
• Develop, generate, analyze, and present TMF metrics/KPIs to leadership
• Lead evolution and oversight of the TMF support model
• Provide operational leadership for TMF vendor budget negotiations and spend management
• Lead/manage relationships with TMF vendors, including contract scope, budgets, performance, and issue resolution
• Serve as TMF Operations representative for systems/processes interfacing with TMF (e.g., CTMS, EDMS, ISF, CDMS/EDC)
• Lead governance committee with TMF Vendors

Responsibilities

• Clinical Operations Reporting and Analytics: Develop and execute reporting and analytics strategies aligned with business objectives
• Create and generate sophisticated reporting, metrics/KPIs, and analytics to measure performance, compliance, and effectiveness
• Interpret metrics to ensure accuracy and provide trends to stakeholders
• Communicate performance metrics and KPIs to study teams, functional leadership, and senior management
• Ensure metrics/reporting solutions are fit-for-purpose, accurate, scalable, and aligned with functionality and budget
• Drive assessment of analytics systems to manage risks and gaps
• Provide oversight across systems to ensure data mapping supports metrics/KPIs and Clinical Operations reporting

Qualifications

• Required: Advanced understanding of ICH-GCP and regulatory requirements as they apply to the TMF
• Required: Experience with document management and electronic TMF systems (e.g., Veeva Vault, Wingspan, Trial Interactive, Documentum)
• Preferred: Extensive experience with Veeva Vault and related applications
• Required: Ability to develop, execute, and assess strategies in TMF and Clinical Systems
• Required: Proficiency in identifying and mitigating risks and communicating them to clinical leadership
• Required: Negotiation and influencing skills for TMF/Clinical Systems challenges
• Required: Experience supporting audits/regulatory inspections
• Required: Advanced experience creating, generating, and analyzing operational clinical trial metrics
• Required: Extensive experience in vendor oversight/management
• Required: Experience owning reporting tools for standard metrics and ad-hoc reporting
• Required: End-to-end understanding of clinical trial phases and document requirements
• Required: Strong leadership and project management in a global matrix environment
• Required: Ability to work independently and with cross-functional teams
• Required: Experience managing people and/or contracted resources
• Required: Knowledge of industry workgroups (e.g., DIA TMF Reference Model)
• Required: Excellent written and oral communication and strong interpersonal skills
• Required: Strong time management, organization, and attention to detail
• Required: Problem solving with clear judgment on regulatory requirements and timelines
• Desirable: Experience implementing/managing CTMS, IRT/RTSM, and eCOA/ePRO systems
• Desirable: Experience with data management/biostatistical systems
• Desirable: Experience developing inspection readiness processes/tools
• Desirable: Prior experience with Veeva Vault eTMF or other Veeva products
• Desirable: Knowledge of regulatory requirements (BLA/MAA submissions) and quality systems

Education

• BA or BS in a science-related field (biological science, medical, pharmacy, or health-related discipline), or equivalent clinical research experience
• Advanced degree preferred
• At least 10 years of relevant clinical research experience in Clinical Operations and/or Clinical Systems/TMF
• Proven computer skills with Microsoft Office and TMF/Document Management applications (e.g., eTMF, EDMS)