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    Clinical Quality Assurance Auditor

    Novocure
    2+ years
    Not Disclosed
    Remote, USA
    10 Aug. 16, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Company Overview:

    Novocure is a global, publicly-traded commercial-stage oncology company dedicated to revolutionizing cancer treatment through our innovative tumor treating fields (TTFields) therapy. TTFields is a non-invasive, novel antimitotic treatment that aims to slow or reverse tumor progression by inducing tumor cell death. Our flagship product, Optune, is approved for treating adult patients with glioblastoma (GBM) in the USA, Europe, and Israel. We are expanding our clinical efforts into other solid tumors, including non-small cell lung cancer and pancreatic cancer.

    Position: Clinical Quality Assurance Auditor

    Location: Root, Switzerland

    Job Summary:

    As a Clinical Quality Assurance Auditor at Novocure, you will play a crucial role in ensuring the quality and compliance of our clinical activities. This role involves conducting QA audits of clinical trials, including investigator site audits and vendor audits, to ensure adherence to Novocure's SOPs, Clinical Investigation Plans, and regulatory guidelines.

    Key Responsibilities:

    • Conduct audits of clinical vendors and investigational sites.
    • Coordinate the activities of Clinical Quality Co-Auditors.
    • Ensure audit results are recorded, reported, and communicated effectively, with timely and thorough documentation of corrective and preventive actions (CAPAs).
    • Follow up on audit outcomes until resolution and ensure timely completion of CAPAs.
    • Manage and maintain databases for the Quality System.
    • Support the preparation of the annual audit plan using a risk-based approach.
    • Participate in and support inspection activities, including preparation, anticipation, support, and hosting of inspections.
    • Lead and contribute to Quality improvement projects and initiatives.
    • Support internal audit activities as needed.
    • Evaluate and manage quality issues, CAPAs, and ensure proper escalation and communication.
    • Prepare and present Quality Reviews and Lessons Learned based on audit and inspection outcomes.
    • Support training activities to enhance Quality Awareness and Inspection Readiness in clinical activities.
    • Ensure compliance with Novocure’s Quality System requirements and meet established timelines.

    Qualifications:

    • Experience in Clinical Quality Assurance or clinical roles within a pharmaceutical or medical device-regulated environment.
    • Proven auditing experience with familiarity in regulatory inspections.
    • Working knowledge of ICH-E6(R2) and ISO 14155:2020.
    • Excellent written and verbal communication skills.
    • Ability to thrive in a fast-paced, dynamic environment with flexibility to adapt to changing priorities.
    • Willingness to travel approximately 60% of the time, both internationally and domestically.

    Application Instructions:

    To apply, please submit your application to Natalia Kochanowicz, Senior Talent Acquisition Partner, via our Applicant Portal. For more information about Novocure and our therapy, visit our website at www.novocure.com or view our patient testimonial videos.

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