Hybrid TMF Specialist (eTMF, Veeva Vault)

Novocure Inc.; Kraków; Hybrid; PLN 134,000 - 179,000; Full time

Job summary

Novocure Inc. invites qualified professionals to join as TMF Specialist in Krakow, Poland. The role focuses on setup, maintenance, and inspection readiness of the electronic TMF across clinical studies, coordinating with CROs and vendors to ensure compliance and audit readiness.

You will monitor QC activities, address TMF gaps, manage CAPAs, and lead TMF close-out with cross-functional teams, while supporting transfer and archiving after study completion.

Qualifications

• Minimum 3 years of experience in clinical operations with TMF focus.
• Proficient knowledge of ICH-GCP, TMF Reference Model, and regulatory requirements.

Responsibilities

• Support CSTs in the setup, maintenance, and inspection readiness of the eTMF across the study lifecycle.
• Coordinate with CROs and vendors to establish TMF Management Plans aligned with standards.
• Monitor QC activities to ensure timely, complete, and accurate TMF documentation.
• Identify TMF quality issues and coordinate resolutions with CSTs and partners.
• Manage CAPAs from audits or internal reviews with timely documentation.
• Ensure inspection readiness aligned with milestones and regulatory expectations.
• Lead TMF close-out activities with CSTs, CROs, and vendors.
• Coordinate transfer and archiving of TMF content after study completion.
• Support implementation of new TMF processes and continuous improvement initiatives.
• Provide TMF best-practice guidance to CSTs and ensure compliance.
• Contribute to TMF training and knowledge sharing across studies.

Skills

Organizational skills

Communication skills

Problem-solving

Education

Bachelor’s degree in Life Sciences/Health Sciences

Tools

Veeva Vault

Wingspan

Job description

Novocure Inc. invites qualified professionals to join as TMF Specialist in Krakow, Poland. The role focuses on setup, maintenance, and inspection readiness of the electronic TMF across clinical studies, coordinating with CROs and vendors to ensure compliance and audit readiness.

You will monitor QC activities, address TMF gaps, manage CAPAs, and lead TMF close-out with cross-functional teams, while supporting transfer and archiving after study completion.