Associate Principal, Clinical & TMF

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

As our next Associate Principal, you will contribute to solving meaningful challenges across the life sciences industry. We offer specialised management consulting services, working with top-tier life sciences companies as well as biotech startups, locally and globally. From strategy development to hands‑on implementation, we support our clients where impact matters most.

About the role

We are looking for an experienced TMF professional ready to move from delivering the work to setting its direction, joining our Clinical Consulting team in Poland. You will bring years of hands‑on Trial Master File experience, owning study TMFs, running quality reviews, and supporting inspections, and apply that experience as the senior TMF expert on our engagements.

In this role you define the standard for TMF quality and hold the solution to it. You will design and specify TMF solutions and verify the configuration delivered by our Veeva specialists, rather than executing it yourself. You will co‑own our TMF competency area alongside a Principal Consultant and act as the senior TMF voice with clients.

You will also help shape how we apply AI to TMF work, bringing the domain judgement these agents need in order to be trusted.

Your responsibilities include:

• Co‑own our TMF offering and capability area alongside a Principal Consultant, contributing to its development and continuous improvement
• Act as the TMF subject matter expert on client engagements and migration projects, owning design decisions, setting the quality standard, and advising specialists on TMF‑specific requirements
• Design and specify TMF solutions, including structure, document classification, metadata, Expected Document Lists, milestones, and reporting, and verify the configuration delivered by our Veeva specialists
• Contribute to our TMF AI initiative as the domain expert, shaping AI agents for automated classification, ALCOA++ checks, functional QC, and inspection readiness by defining the rules they apply and validating their output
• Act as a trusted advisor to clients on TMF best practices, inspection readiness, and TMF health and completeness, and establish TMF governance including TMF plans, SOPs, roles and responsibilities, and quality control processes
• Lead workstreams or project teams, ensuring high‑quality delivery and stakeholder alignment
• Conduct TMF process assessments, facilitate requirements workshops, and drive change management activities including training design and adoption planning
• Mentor junior consultants to strengthen internal TMF capability, and engage in sales processes by contributing to RfP responses and scoping

You bring:

• 4-5 years of experience in Trial Master File management at a sponsor, a CRO, or in consulting, including ownership of a study TMF or participation in TMF implementation programmes
• Deep working knowledge of Veeva Vault eTMF, with the 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 adapting the model to a sponsor’s operating reality
• Strong track record in TMF quality and inspection readiness, including completeness and timeliness metrics, TMF health monitoring, QC processes, and support for inspections and audits
• Hands‑on experience with TMF governance, including TMF plans, SOPs, oversight of the TMF for CRO‑run trials, and TMF transfer and reconciliation with CRO partners
• Solid knowledge of GCP / ICH E6 and regulatory expectations for trial documentation (EMA, FDA), together with practical experience of GxP validation and computerised system compliance (e.g. 21 CFR Part 11, Annex 11)
• Contribute on solution design on complex, multi‑stakeholder implementations, with excellent problem‑solving and analytical skills
• Strong communication skills, both verbal and written, in English
• Ability to create compelling presentations and confidently present to diverse audiences
• A proactive mindset, comfortable working in agile teams and remote environments, with a genuine interest in developing others

It will be a plus if you have these additional capabilities:

• Veeva certification in Vault eTMF or the Vault Platform
• Knowledge of adjacent Vault Clinical applications (CTMS, Study Startup) or of RIM, Quality, or Safety domains
• Participation in a regulatory inspection or sponsor audit where the TMF was in scope
• Prior consulting experience is valued but not required
• Experience with Project Management and Agile methodologies (certifications such as Agile or PMP will be a plus)
• Experience with project management and collaboration tools such as Jira, Confluence, or similar platforms

This position is offered in Poland.

Who is BASE life science?

Founded in 2007, BASE life science is a business and technology consulting enterprise working exclusively in the life sciences industry.

With headquarters in Denmark and offices across Europe and the United States, we support clients globally. We work closely with our customers to identify, develop, and implement initiatives that drive growth, efficiency, and meaningful change. Through partnerships with leading solution providers such as Veeva, Salesforce, IQVIA, and MediSpend, we help our clients unlock the full potential of modern technologies.

Why join BASE life science?

At BASE, you work on meaningful, complex challenges at the intersection of technology, science, and business. We trust our people with real responsibility and support them in turning ambition into impact.

You will be part of a collaborative, high‑performing environment where:

• Ambition is encouraged through ownership and continuous learning
• Execution matters: we focus on delivering solutions that work in practice
• Team spirit and trust guide collaboration across roles, countries, and disciplines
• Openness means your ideas are heard, you are challenged constructively, and supported as you grow

Alongside this, we offer:

• Flexible ways of working, built on trust, autonomy, and balance
• Ongoing learning and professional development throughout your career
• A modern work setup, with the tools and equipment needed to do great work
• Recognition of performance and impact, linked to contribution and results
• The opportunity to work on challenges that make a meaningful difference for patients and healthcare systems worldwide

Explore our work, values, and people at www.baselifescience.com

At BASE life science, we value diverse backgrounds, experiences, and perspectives. Employment decisions are based solely on qualifications, merit, and business needs