Senior TMF Strategy & Quality Lead – Global Trials

BASE life science; Polska; Hybrid; PLN 140,000 - 210,000; Full time

Benefits offered by this job

Flexible working

Learning & development

Modern work setup

Recognition of impact

Global patient impact

Job summary

BASE life science in Poland is seeking an Associate Principal TMF expert to lead TMF quality standards, design TMF solutions, and guide clients through audits.

You will co-own TMF offering, mentor consultants, and shape AI-driven classification and inspection readiness.

This role blends life sciences consulting with regulatory excellence, working with CROs, sponsors, and biotech clients across Europe.

Qualifications

• 4-5 years of TMF management experience in sponsor, CRO, or consulting
• Deep knowledge of Veeva Vault eTMF and TMF model including classification, metadata, milestones and reporting
• Strong understanding of TMF Reference Model and artefact mapping
• Proven track record in TMF quality, inspection readiness, and audits
• Experience with TMF governance, plans, SOPs, and CRO/ sponsor oversight
• Knowledge of GCP/ICH E6, EMA/FDA expectations, and 21 CFR Part 11/Annex 11
• Excellent problem-solving, analytical skills, and multi-stakeholder design
• Strong communication in English and ability to present to diverse audiences
• Agile mindset and comfort with remote collaboration

Responsibilities

• Co-own our TMF offering and contribute to its development
• Act as the TMF subject matter expert on client engagements and migrations
• Design and specify TMF solutions including structure, metadata, and reports
• Contribute to our TMF AI initiative and define rules for automated classification
• Advise clients on TMF best practices, inspections, and governance
• Lead workstreams, ensure high-quality delivery and stakeholder alignment
• Conduct TMF process assessments and facilitate requirements workshops
• Mentor junior consultants and contribute to RfP responses and scoping

Skills

TMF expertise

English communication

Project management

Agile teamwork

Stakeholder management

Tools

Veeva Vault eTMF

Job description

BASE life science in Poland is seeking an Associate Principal TMF expert to lead TMF quality standards, design TMF solutions, and guide clients through audits.

You will co-own TMF offering, mentor consultants, and shape AI-driven classification and inspection readiness.

This role blends life sciences consulting with regulatory excellence, working with CROs, sponsors, and biotech clients across Europe.