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    Clinical Trial Safety Associate

    Endotronix Inc
    2+ years
    $65,000 to $85,000 per year
    Naperville
    10 July 25, 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, 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

    Position: Clinical Trial Safety Associate

    Location: Hybrid, Endotronix (Heart Failure Device Specialist)

    Salary Range: $65,000 to $85,000 per year

    About Endotronix:

    Endotronix is a leading medical device company focused on transforming heart failure treatment. Our Cordella Heart Failure System (CHFS) offers proactive management tools that enhance patient quality of life and reduce hospital admissions. With recent FDA PMA approval, we are expanding our team. Join us during this exciting growth phase!

    Key Responsibilities:

    • Adverse Event Review: Evaluate adverse event reports (AERs) to determine regulatory reporting requirements.
    • Clinical Narratives: Review and analyze clinical narratives related to adverse events.
    • Communication: Liaise with the Safety Department, CRO, and other stakeholders for additional information on adverse events.
    • Regulatory Reporting: Assist in preparing reports for regulatory submissions regarding device safety.
    • Literature Monitoring: Stay updated on the latest safety information related to the company's products.
    • Collaboration: Work with Clinical Science, R&D, Regulatory Affairs, and other departments to ensure compliance with safety regulations.
    • Safety Guidelines: Participate in developing and implementing safety guidelines and procedures.
    • Risk Management: Contribute to the development and execution of risk management plans.

    Qualifications:

    • Experience: 2+ years in the medical device, biotechnology, or pharmaceutical industry, focusing on clinical trial safety. Experience with medical devices or safety management in a biotech/startup/CRO environment is preferred.
    • Regulatory Knowledge: Understanding of clinical trial regulations for medical devices (21 CFR 820, 803, ISO 13485, euMDR 2017/745).
    • Reporting Experience: Familiarity with medical device clinical trial case reporting, including Serious Adverse Event (SAE) reports and Device Deficiency (DD) reports.
    • Statistical Skills: Strong background in statistical methods for evaluating complaint trends and establishing thresholds.
    • Data Management: Proficiency in developing and managing information systems for tracking and trending data.
    • Communication Skills: Excellent verbal and written communication skills.
    • Technical Proficiency: Advanced knowledge of Microsoft Office Suite and experience with electronic databases (e.g., Argus).

    Educational Requirements:

    • Associate or Bachelor's degree in Biomedical Engineering, Clinical Research, Medical Technology, or other life sciences fields is preferred.

    Ideal Candidate:

    • Data-Driven: Relentlessly focused on data and hypothesis-driven decision-making.
    • Action-Oriented: Preference for action and quick iteration over perfection.
    • Collaborative: Effective communicator who can synthesize insights from multiple stakeholders.
    • Team Player: Inspires teams to deliver collective results.
    • Passionate: Keen interest in digital healthcare and leveraging data to deliver innovative solutions.

    Company Culture:

    At Endotronix, we value direct and honest communication, a competitive spirit, and a commitment to continual learning and improvement. We thrive in a dynamic and complex environment, emphasizing teamwork, intellectual curiosity, and humility.

    Life at Endotronix:

    We offer a competitive compensation package, comprehensive benefits including unlimited PTO, and a supportive environment to help you succeed in your career. Endotronix is an equal-opportunity employer, committed to diversity and inclusion in the workplace.

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