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    Medical Device Clinical Trial Consultant

    Beacon Hill
    5+ years
    Not Disclosed
    Remote, USA
    10 Nov. 14, 2024
    Job Description
    Job Type: Full Time Remote 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

    Job Title: Clinical Trial Consultant for Wearable Device Technology

    Job Overview:

    We are looking for a motivated Clinical Trial Consultant to lead our clinical trials in wearable device technology. This role involves strategic oversight, hands-on involvement, and decision-making to ensure trials run smoothly and efficiently. You’ll collaborate with data consultants, engineers, and clinical teams to assess real-time data and make informed adjustments to trial protocols and device performance. This is a critical role that bridges clinical and technical functions, contributing directly to the progress of our innovative technology.

    Key Responsibilities:

    • Lead Clinical Trials: Take charge of clinical trial execution, working cross-functionally to ensure each phase advances smoothly and meets regulatory standards.
    • Data Oversight and Insights: Work closely with data consultants and engineers to analyze and validate trial data, implementing necessary adjustments to optimize outcomes.
    • Strategic Decision-Making: Evaluate data trends and make proactive adjustments to refine trial protocols and enhance device performance.
    • Engineering Collaboration: Collaborate with engineering teams to address technical issues and incorporate changes based on clinical trial findings, ensuring device accuracy and functionality.
    • Vendor and Contractor Management: Oversee external vendors and contractors to ensure alignment with project goals, timelines, and quality benchmarks.
    • Regulatory Compliance: Ensure all trial data collection and submissions comply with FDA regulations, ISO 13485, and other medical standards.
    • Technical Support: Provide guidance to engineering and data teams, ensuring clinical and technical alignment.

    Qualifications:

    • Education: Bachelor’s or Master’s degree in Biomedical Engineering, Clinical Research, or a related field.
    • Experience: 5+ years in clinical trials within the medical device industry, ideally with wearable tech or remote patient monitoring.
    • Leadership & Decision-Making: Proven ability to make data-driven decisions and lead clinical teams effectively.
    • Data & Analytical Skills: Ability to interpret clinical data, ensure data accuracy, and adjust protocols or settings as needed.
    • Regulatory Knowledge: Strong understanding of FDA regulations and clinical protocols, including experience with 510(k) submissions for medical devices.
    • Communication: Excellent communication skills to align technical and non-technical teams.
    • Problem-Solving: Skilled at resolving complex issues in real-time and adapting to trial challenges.

    Notes:

    • Location: Hybrid role based in Philadelphia; onsite presence is required during initial trial phases.
    • Startup Adaptability: This is a fast-paced environment where you’ll take initiative and multitask as needed.
    • Collaboration: Work closely with the CEO and key stakeholders to ensure alignment of clinical and business goals.

    This is an exciting opportunity to join a startup where your expertise can make a direct impact on advancing wearable health technology.

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