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    Clinical Operations Lead - Fort Worth, United States - Astrix

    Astrix
    Astrix Fort Worth, United States

    2 weeks ago

    Default job background
    Manufacturing / Mechanical
    Description

    Exciting Clinical Operations Lead opportunity to work for a global leader dedicated to helping people see brilliantly. The largest device company in the world – with complementary businesses in Surgical and Vision Care.

    • Perform project management tasks at country, regional and site level in support of planning, conduct and reporting of clinical trials.
    • Successful implementation and execution of assigned trial(s) in compliance with guidelines, regulations, and procedures.
    • Ensure trial conduct is efficient, with seamless execution, achievement of timelines and study deliverables with quality, and full compliance with international guidelines, local regulations and corporate policies and procedures.
    • Lead the site management team responsible for operational activities for study/site activation, conduct, and close-out of 2-3 clinical trials of low to medium complexity
    • Provide operational feasibility/site management input to the development of the protocol, manual of procedures, informed consent template, data validation plan, and other documents as required.
    • Develop Protocol Monitoring Plan (PMP).
    • Lead a team of Clinical Site Managers (CSMs) for assigned trial(s), tracking site progress, achievements, and status of CSM activities.
    • Proactively identify potential/actual issues and risks, bring up to management as appropriate, and contribute to mitigation
    • Coordinate study activities with assigned CSMs, reinforcing compliance with PMP, relevant procedures, and applicable regulations
    • Coordinate, prepare, deliver, and track protocol specific training for site personnel and assigned CSMs
    • Actively participate on the Clinical Trial Team (CTT), building relationships and serving as liaison among trial team personnel as appropriate
    • Facilitate communication between CTT and sites throughout the trial

    Preferred Qualifications:

    • Bachelor's Degree in life science; medical, pharmaceutical, biology, chemistry degree preferred.
    • 5 years of direct experience as Clinical Operations Lead or clinical trial management experience. (not a Clinical Trials Manager)
    • OP Lead or Trial Management experience
    • Must have lead experience (Preferred 6 years, Minimum to be considered 4 years)
    • Ophthalmology experience (Must have)
    • Medical Device or Pharma experience

    This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you

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