TMF (Trial Master File) 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. 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. We are looking forward to receive your application to Karolina Zwolak-Grzybek, Senior Talent Acquisition Partner through our Applicant Portal. Please find more information about Novocure and our therapy on our website www.novocure.com