Associate Principal, Clinical, TMF

This is a fully remote position, open to applicants in Poland.

📋 Description

• Share ownership of the TMF offering and capability area in collaboration with a Principal Consultant.

• Serve as the TMF subject matter expert on client projects and migration initiatives.

• Take responsibility for design decisions, establish quality standards, and advise specialists on TMF-specific needs.

• Develop and detail TMF solutions encompassing structure, document classification, metadata, Expected Document Lists, milestones, and reporting.

• Validate configurations provided by Veeva specialists.

• Shape AI agents for automated classification, ALCOA++ checks, functional quality control, and inspection readiness.

• Set rules for TMF AI agents and assess their outputs.

• Provide guidance to clients regarding TMF best practices, inspection readiness, TMF health, and completeness.

• Create TMF governance frameworks, which include TMF plans, SOPs, roles and responsibilities, and quality control processes.

• Lead project teams or workstreams, ensuring high-quality deliverables and alignment with stakeholders.

• Conduct TMF process evaluations and facilitate requirement workshops.

• Drive change management initiatives, design training programs, and plan for adoption.

• Mentor junior consultants and enhance internal TMF capabilities.

• Contribute to sales efforts through RfP responses and project scoping.

⛳️ Requirements

• 4–5 years of experience managing Trial Master Files at a sponsor, CRO, or consulting firm.

• Proven ownership of a study TMF or involvement in TMF implementation programs.

• Extensive knowledge of Veeva Vault eTMF.

• Capability to design and verify configurations related to document classification, metadata, Expected Document Lists, milestones, and reporting.

• Expert understanding of the TMF Reference Model, including index and structure design, artefact mapping, and adaptation to sponsor operational realities.

• Strong history of ensuring TMF quality and inspection readiness.

• Familiarity with completeness and timeliness metrics, TMF health monitoring, quality control processes, inspections, and audits.

• Practical experience in TMF governance, TMF plans, SOPs, CRO oversight, TMF transfer, and reconciliation.

• Knowledge of GCP / ICH E6 and regulatory requirements from EMA and FDA.

• Hands-on experience with GxP validation and compliance of computerized systems, including 21 CFR Part 11 and Annex 11.

• Experience in contributing to solution design for complex, multi-stakeholder implementations.

• Superior problem-solving and analytical capabilities.

• Strong verbal and written communication skills in English.

• Ability to craft compelling presentations and present confidently to diverse audiences.

• Proactive approach and adaptability to working in agile teams and remote settings.

• Genuine passion for mentoring others.

• Veeva certification in Vault eTMF or Vault Platform is advantageous.

• Familiarity with adjacent Vault Clinical applications, RIM, Quality, or Safety domains is a plus.

• Experience participating in regulatory inspections or sponsor audits involving TMF is a bonus.

• Previous consulting experience is appreciated but not mandatory.

• Project Management or Agile experience/certification is a plus.

• Familiarity with Jira, Confluence, or similar tools is an advantage.

• Applications must be submitted in English.

🏝️ Benefits

• Flexible working arrangements fostered by trust, autonomy, and balance.

• Continuous learning and professional growth opportunities throughout your career.

• Modern work environment equipped with the necessary tools and resources for exceptional performance.

• Recognition of contributions and achievements linked to performance and impact.

• Chance to tackle challenges that significantly benefit patients and healthcare systems globally.

• A collaborative, high-performance work culture.

• Opportunities for ongoing learning and ownership.