TMF Associate

TFS HealthScience; Warszawa; Remote; PLN 70.000 - 95.000; Vollzeit

Zusammenfassung

TFS HealthScience is seeking a Trial Master File (TMF) Associate for a home-based role in Poland within the CDS Dermatology team. You will organize, maintain, and oversee TMFs to ensure audit-ready documentation throughout the study lifecycle, collaborating with study teams, sponsors, and QA.

The ideal candidate has 1-2 years TMF experience, familiarity with ICH-GCP TMF requirements, and strong attention to detail and communication skills. This remote position offers growth within a global CRO.

Qualifikationen

• Bachelor's degree in Health Sciences or related field.
• 1-2 years TMF experience.
• Knowledge of ICH-GCP TMF requirements.
• Strong organizational and multitasking skills.
• Excellent written and verbal communication.

Aufgaben

• Establish and maintain TMFs per company procedures and regs.
• Develop study-specific TMF Plans and provide TMF training.
• Perform document QC reviews to ensure TMF completeness and accuracy.
• Monitor TMF metrics and drive resolution of issues.
• Prepare and distribute monthly TMF status reports.
• Coordinate TMF reconciliation and sponsor transfers.

Kenntnisse

TMF knowledge

GCP awareness

Detail-oriented

Communication skills

Ausbildung

Bachelor's degree in Health Sciences

Tools

TMF software

Jobbeschreibung

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.

Join Our Team as a TMF Associate, home-based in Poland.

About this role

As part of our CDS Dermatology team you will be working alongside passionate and innovative professionals to ensure our customers achieve their goals.
As a Trial Master File Associate, you will play a critical role in supporting study teams by organizing, maintaining, and overseeing Trial Master Files (TMFs) throughout the study lifecycle. You will ensure TMFs remain audit- and inspection-ready, support quality processes, and collaborate closely with project teams, sponsors, and internal stakeholders to maintain compliance with regulatory requirements and company standards.

Key Responsibilities:

• Establish and maintain Trial Master Files (TMFs) in accordance with company procedures and regulatory requirements.


• Develop and maintain study-specific TMF Plans and provide TMF-related training to study teams.


• Perform document quality control reviews and reconciliation activities to ensure TMF completeness and accuracy.


• Monitor TMF metrics, identify quality or compliance issues, and drive resolution activities.


• Prepare and distribute monthly TMF status reports to project and functional leadership.


• Coordinate TMF reconciliation activities and support document transfer processes to sponsors.


• Ensure TMFs remain submission-, inspection-, and audit-ready throughout the study lifecycle.


• Serve as the primary TMF contact for study teams, providing guidance and support on TMF processes and requirements.


• Participate in study team meetings and provide updates on TMF quality and status.


• Support audits, inspections, and quality improvement initiatives.


• Set up and maintain Investigator Site Files (ISFs) when required.

Qualifications:

• Bachelor's degree in Health Sciences, Document Management, or a related field, or equivalent work experience.


• 1-2 years of experience working with TMF.


• Knowledge of ICH-GCP guidelines and TMF requirements.


• Strong organizational and multitasking skills with a keen attention to detail.


• Excellent written and verbal communication skills.

What We Offer

We provide a competitive compensation package, comprehensive benefits and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients

A Bit More About Us

Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology and Ophthalmology.

Our core values of Trust, Quality, Passion, Flexibility and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration.