Trial Master File Specialist - 6-months fixed-term contract

Novocure; Kraków; Sur place; PLN 134 000 - 179 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Organizational skills

Communication skills

Problem-solving

Formation

Bachelor’s degree in Life Sciences/Health Sciences

Outils

Veeva Vault

Wingspan

Description du poste

Novocure is a global publicly-traded commercial-stage oncology company developing a profoundly different cancer treatment therapy called Tumor Treating Fields (TTFields) for patients with solid tumors. TTFields therapy is a non-invasive, novel, antimitotic treatment modality which utilizes proprietary technology attempting to slow or reverse tumor progression by inducing tumor cell death. Novocure's commercialized product, Optune, is approved for the treatment of adult patients with glioblastoma (GBM) in the USA, Europe and Israel. Novocure has ongoing or completed clinical trials and is further expanding its efforts into several other solid tumor indications - non-small cell lung cancer, pancreatic cancer and other types of solid cancers.

JOB SUMMARY:

The Trial Master File (TMF) Specialist plays a key role in supporting Clinical Study Teams (CSTs) with the setup, maintenance, and inspection readiness of the electronic Trial Master File (eTMF) throughout the lifecycle of clinical studies. Reporting to the Operational Excellence Lead – TMF, the TMF Specialist ensures high-quality TMF documentation, compliance with regulatory requirements, and alignment with internal standards.

TMF Specialist collaborates closely with Contract Research Organizations (CROs), vendors, and internal stakeholders to implement and maintain TMF processes, perform quality control (QC) activities, and support continuous improvement initiatives. TMF Specialist contributes to audit readiness and supports the long-term archiving of TMF content.

This is a full-time role based in Krakow, within a department of Global Clinical Operations reporting to the Operational Excellence Lead-TMF.

This is hybrid position that requires office presence 3 times per week. We offer a 6-months fixed-term employee contract.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• 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 Corrective and Preventive Actions (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.

QUALIFICATIONS/KNOWLEDGE:

Qualifications:

• Bachelor’s degree in Life Sciences, Health Sciences, or related field.

Knowledge:

• Minimum 3 years of experience in clinical operations, with a strong focus on TMF management
• In-depth knowledge of ICH-GCP, TMF Reference Model, and regulatory requirements
• Strong organizational, communication, and problem-solving skills.
• Ability to work independently and collaboratively in a fast-paced environment.Experience working with CROs and external vendors.
• Familiarity with TMF metrics, inspection readiness strategies, and CAPA management.
• Exposure to operational excellence or process improvement initiatives.
• Experience working with eTMF systems (experience with Veeva Vault is a must, experience with Wingspan is a nice to have).

COMPENSATION:

The annual base salary ranges from 12.000 PLN gross to 16.000 PLN gross monthly*.

This pay range is the range of base pay compensation within which Novocure expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and skills demonstrated.