Associate Principal, Clinical, TMF

Job Responsibilities

• 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

Requirements

• 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

Core Competencies

Demonstrates expertise in Trial Master File (TMF) management, including design, governance, and quality control processes. Proficient in Veeva Vault eTMF and regulatory compliance, with strong analytical and communication skills to lead client engagements and mentor teams.

Highest-signal resume keywords

• Trial Master File Management
• Veeva Vault eTMF
• TMF Governance
• GCP / ICH E6 Knowledge
• TMF Quality and Inspection Readiness

ATS Optimization Keywords

Hard Skills

• Document Classification
• Metadata Design
• Expected Document Lists
• TMF Reference Model
• TMF Health Monitoring
• Quality Control Processes
• GxP Validation
• Computerized System Compliance
• Solution Design
• Regulatory Inspection Participation

Soft Skills

• Problem-Solving
• Analytical Skills
• Verbal Communication
• Written Communication
• Mentoring

Certifications & Qualifications

• Veeva Certification in Vault eTMF
• Project Management Certification
• Agile Certification

Industry Keywords

• TMF Implementation
• CRO Oversight
• SOPs
• Regulatory Expectations
• FDA Compliance
• EMA Compliance

Tools & Technologies

• Jira
• Confluence
• Veeva Vault Platform
• Agile Methodologies

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