Associate Principal, Clinical, TMF

• Co-own the TMF offering and capability area alongside a Principal Consultant
• Act as the TMF subject matter expert on client engagements and migration projects
• Own design decisions, set quality standards, and advise specialists on TMF-specific requirements
• Design and specify TMF solutions covering structure, document classification, metadata, Expected Document Lists, milestones, and reporting
• Verify configuration delivered by Veeva specialists
• Shape AI agents for automated classification, ALCOA++ checks, functional QC, and inspection readiness
• Define rules for TMF AI agents and validate their output
• Advise clients on TMF best practices, inspection readiness, TMF health, and completeness
• Establish TMF governance, including TMF plans, SOPs, roles and responsibilities, and quality control processes
• Lead workstreams or project teams and ensure high-quality delivery and stakeholder alignment
• Conduct TMF process assessments and facilitate requirements workshops
• Drive change management, training design, and adoption planning
• Mentor junior consultants and strengthen internal TMF capability
• Contribute to sales processes through RfP responses and scoping

• 4–5 years of experience in Trial Master File management at a sponsor, CRO, or consulting firm
• Ownership of a study TMF or participation in TMF implementation programmes
• Deep working knowledge of Veeva Vault eTMF
• Ability to design and verify configuration covering document classification, metadata, Expected Document Lists, milestones, and reporting
• Expert command of the TMF Reference Model, including index and structure design, artefact mapping, and adaptation to sponsor operating realities
• Strong track record in TMF quality and inspection readiness
• Experience with completeness and timeliness metrics, TMF health monitoring, QC processes, inspections, and audits
• Hands-on experience with TMF governance, TMF plans, SOPs, CRO oversight, TMF transfer, and reconciliation
• Knowledge of GCP / ICH E6 and regulatory expectations from EMA and FDA
• Practical experience with GxP validation and computerized system compliance, including 21 CFR Part 11 and Annex 11
• Experience contributing to solution design on complex, multi-stakeholder implementations
• Excellent problem-solving and analytical skills
• Strong verbal and written communication skills in English
• Ability to create compelling presentations and present confidently to diverse audiences
• Proactive mindset and comfort working in agile teams and remote environments
• Genuine interest in developing others
• Veeva certification in Vault eTMF or Vault Platform is a plus
• Knowledge of adjacent Vault Clinical applications, RIM, Quality, or Safety domains is a plus
• Participation in a regulatory inspection or sponsor audit where TMF was in scope is a plus
• Prior consulting experience is valued but not required
• Project Management or Agile experience/certification is a plus
• Experience with Jira, Confluence, or similar tools is a plus
• Must submit application in English

• Flexible ways of working, built on trust, autonomy, and balance
• Ongoing learning and professional development throughout your career
• Modern work setup with the tools and equipment needed to do great work
• Recognition of performance and impact, linked to contribution and results
• Opportunity to work on challenges that make a meaningful difference for patients and healthcare systems worldwide
• Collaborative, high-performing environment
• Continuous learning and ownership opportunities