Associate Director, TMF Operations and Clinical Operations Analytics

Role Summary

Associate Director, TMF Operations and Clinical Operations Analytics. Location: Conshohocken, PA or Gaithersburg, MD. Department: Clinical Operations.

Responsibilities

• TMF Operations: Accountable for the company‚Äôs Trial Master File support model, processes, and systems
• Responsible for oversight and management of TMF vendors and associated processes for the TMF
• Primary point of contact related to TMF processes and systems and study specific TMF support, as appropriate
• Develop and oversee global TMF-related standards, SOPs and corresponding controlled documents in line with regulations and industry best practices
• Provide expertise and leadership to ensure inspection readiness and support audits/regulatory inspections
• Review TMF operations input into clinical documents, particularly study plans
• Develop, generate, analyze, and present TMF metrics/KPIs to demonstrate TMF health
• Lead evolution/implementation/oversight of TMF support model
• Provide operational leadership to TMF vendor budget negotiations and management of TMF operations spend
• Lead/manage relationship with TMF vendors; contract scope, budgets, performance, 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

• 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, effectiveness
• Interpret metrics/analytics, ensure accuracy, and communicate to study teams and leadership
• Ensure metrics/reporting/analytics solutions are fit for purpose, aligned, accurate, scalable, and within budget
• Assess systems supporting analytics to manage risks and gaps
• Provide business oversight across systems to ensure data mapping supports metrics/KPIs and reporting

Qualifications

• Essential: Advanced understanding of ICH-GCP and regulatory requirements for TMF
• Essential: Experience with document management and electronic TMF systems (e.g., Veeva Vault, Wingspan, Trial Interactive, Documentum)
• Essential: Extensive experience with Veeva Vault; strong preference for Veeva applications
• Essential: Ability to develop/execute strategies to enhance TMF/Clinical Systems; risk identification/mitigation
• Essential: Negotiation and influence skills; experience supporting audits/regulatory inspections
• Essential: Advanced experience creating and analyzing operational clinical trial metrics
• Essential: Vendor oversight/management experience; ownership of reporting tools
• Essential: End-to-end understanding of clinical trial phases and document requirements
• Essential: Leadership and project management; ability to work in a global matrix
• Essential: Independent work capability; cross-functional collaboration
• Essential: Experience managing people/contracted resources; familiarity with DIA TMF Reference Model
• Essential: Excellent communication and time management
• Essential: Detail-oriented with problem-solving and regulatory judgment

• Desirable: Experience with CTMS, IRT/RTSM, eCOA/ePRO; data management/biostatistical systems
• Desirable: Experience developing inspection readiness processes/tools; Veeva Vault eTMF
• Desirable: Knowledge of regulatory requirements (BLA/MAA) and quality systems

Education

• BA/BS in science or related field; advanced degree preferred
• At least 10 years of relevant clinical research experience in Clinical Operations/Clinical Systems/TMF
• Proven computer skills and TMF/Document Management applications (eTMF, EDMS)