Clinical Trial Documentation Specialist- 6-months fixed-term contract

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.