TMF Specialist - Remote (Poland)

TFS HealthScience; Województwo mazowieckie; A distancia; PLN 60.000 - 85.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive pay

Benefits

Growth opportunities

Descripción de la vacante

TFS HealthScience is seeking a TMF Associate to join our CDS Dermatology team from a home-based setup in Poland. You will establish and maintain Trial Master Files, develop TMF plans, and ensure TMF readiness for audits and inspections. Strong organizational and communication skills are essential.

Minimum 1–2 years TMF experience and a Bachelor’s degree in Health Sciences or related field are required. The role emphasizes training, quality control, and collaboration with study teams worldwide.

Formación

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

Responsabilidades

• 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.

Conocimientos

TMF knowledge

ICH-GCP knowledge

Organization & multitasking

Communication skills

Documentation management

Educación

Bachelor's degree in Health Sciences / Document Management or related field

Descripción del empleo

TFS HealthScience is seeking a TMF Associate to join our CDS Dermatology team from a home-based setup in Poland. You will establish and maintain Trial Master Files, develop TMF plans, and ensure TMF readiness for audits and inspections. Strong organizational and communication skills are essential.

Minimum 1–2 years TMF experience and a Bachelor’s degree in Health Sciences or related field are required. The role emphasizes training, quality control, and collaboration with study teams worldwide.