TMF Specialist: eTMF Mastery & Audit Readiness

Novocure; Kraków; Hybride; PLN 134 000 - 179 000; Plein temps

Avantages offerts par ce poste

Hybrid work 3 days/week

6-month fixed-term contract

Résumé du poste

Novocure is seeking a TMF Specialist in Krakow to support Clinical Study Teams with the setup, maintenance, and inspection readiness of the eTMF across study lifecycles. This full-time role blends hands-on document management with regulatory compliance.

You will collaborate with CROs and vendors to ensure timely, complete, and compliant TMF documentation, lead CAPA activities, and drive audit readiness. The position offers hybrid work (office presence 3 days/week) and a 6-month fixed-term

Qualifications

• Bachelor’s degree in Life Sciences, Health Sciences, or related field.
• Minimum 3 years of experience in clinical operations, with a strong focus on TMF management.
• Experience with eTMF systems (Veeva Vault required; Wingspan a plus).
• Strong organizational, communication, and problem-solving skills.
• Ability to work independently and collaboratively in a fast-paced environment.

Responsabilités

• Support CSTs in the setup, maintenance, and ongoing inspection readiness of the eTMF throughout the clinical study lifecycle.
• Collaborate with CROs and vendors to establish and maintain TMF Management Plans aligned with study-specific and organizational standards.
• Monitor and oversee QC activities performed by CROs, vendors, and CSTs to ensure timely, complete, and accurate TMF documentation.
• Identify and track TMF quality issues and documentation gaps, coordinate resolution with CSTs and external partners.
• Manage TMF-related CAPAs resulting from audits or internal reviews, ensuring timely resolution and documentation.
• Continuously assess TMF status to ensure inspection readiness in alignment with study milestones and regulatory expectations.
• Lead TMF close-out activities in collaboration with CSTs, CROs, and vendors, ensuring completeness, accuracy, and compliance.
• Coordinate with the Operational Excellence Lead – TMF on the transfer and archiving of TMF content following study completion.
• Support the implementation of new or updated TMF processes, tools, and continuous improvement initiatives across studies.
• Provide guidance to CSTs on TMF best practices, documentation standards, and compliance requirements.
• Contribute to TMF-related training and knowledge-sharing initiatives to promote consistency and quality across clinical studies.

Connaissances

TMF management

Clinical operations

Regulatory compliance

CRO collaboration

Project coordination

Quality control

CAPA management

eTMF systems

Formation

Bachelor’s degree in Life Sciences or related field

Outils

Veeva Vault

Wingspan

Description du poste

Novocure is seeking a TMF Specialist in Krakow to support Clinical Study Teams with the setup, maintenance, and inspection readiness of the eTMF across study lifecycles. This full-time role blends hands-on document management with regulatory compliance.

You will collaborate with CROs and vendors to ensure timely, complete, and compliant TMF documentation, lead CAPA activities, and drive audit readiness. The position offers hybrid work (office presence 3 days/week) and a 6-month fixed-term