NO

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

Novocure remote Posted 27 Oct 2026 Closing: 26 Nov 2026
Permanent
Competitive
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Job Description & Overview

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.

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    Key Details
    • Date Posted: 27 Oct 2026
    • Location: remote
    • Employment Type: Permanent
    • Category: General
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    Employer Information
    NO
    Novocure
    Verified Transport Employer

    Verified transport and logistics firm operating commercial fleets across the UK network.

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