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 TMF support model, processes, and systems; oversight and management of TMF vendors and related processes; primary point of contact for TMF processes and study-specific TMF support; develop and oversee global TMF standards, SOPs, and controlled documents in line with regulations and industry best practices; ensure inspection readiness and seamless audits/regulatory inspections; review TMF input into clinical documents (e.g., study plans); develop, generate, analyze, and present TMF metrics/KPIs; lead evolution of the TMF support model; lead TMF vendor budget negotiations and management; manage TMF vendor relationships; represent TMF Operations in system/process integrations (CTMS, EDMS, ISF, CDMS/EDC); lead TMF vendor governance committees.
• Clinical Operations Reporting and Analytics: Develop and execute Clinical Operations reporting/analytics strategies; create sophisticated reporting and KPIs to measure performance, compliance, and effectiveness; interpret metrics and trends for stakeholders; communicate performance metrics to study teams and leadership; ensure metrics/solutions are fit for purpose, accurate, scalable, and within budget; assess systems supporting analytics and reporting to manage risks and gaps; provide business oversight across systems to ensure data alignment for metrics and reporting.

Qualifications

• Essential: Advanced understanding of ICH-GCP and regulatory requirements for TMF; experience with document management and electronic TMF systems (e.g., Veeva Vault, Wingspan, Trial Interactive, Documentum); extensive experience with Veeva Vault and related applications preferred; ability to develop/exectute strategies in TMF/Clinical Systems; risk identification/mitigation with clear communication to leadership; negotiation and influencing skills; experience supporting audits/regulatory inspections; advanced experience in clinical trial metrics; vendor oversight experience; ownership of reporting tools for standard/ad-hoc metrics; end-to-end understanding of clinical trial phases and document requirements; strong leadership, project management, and ability to work in a global matrix; independent work capability; experience managing staff or contracted resources; familiarity with DIA TMF Reference Model; excellent written/oral communication and interpersonal skills; strong time management and attention to detail; problem-solving and judgement in regulatory contexts.
• Desirable: Experience implementing/managing CTMS, IRT/RTSM, eCOA/ePRO; data management/biostatistical systems; inspection readiness processes/tools; Veeva Vault eTMF or other Veeva products; knowledge of regulatory requirements for BLA/MAA submissions and quality systems.
• Education: BA/BS in science or related field; advanced degree preferred; 10+ years in clinical research/Clinical Operations or Clinical Systems/ TMF; proficiency with Microsoft Word/PowerPoint/Project/Excel/SharePoint/Adobe Acrobat and TMF/Document Management apps (eTMF, EDMS).

Education

• BA or BS in a science-related field; advanced degree preferred.
• At least 10 years of relevant clinical research experience in biotechnology/pharmaceutical industry or CRO, with focus on Clinical Operations and/or TMF/Clinical Document Management.
• Proficiency with Microsoft Office and TMF/Document Management applications (eTMF, EDMS).