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    Director of Clinical Studies - Warminster, United States - LifeLens Technologies, LLC.

    LifeLens Technologies, LLC.
    LifeLens Technologies, LLC. Warminster, United States

    3 weeks ago

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    Description
    Job Description

    Job Description Salary:
    commensurate with experience
    LifeLens Technologies, Inc. is a medical device developer located in beautiful Bucks County, PA. We are pioneering innovative, next-generation treatment devices for personal health monitoring.


    We are seeking an experienced, collaborative, hands-on leader accountable to drive the design, implementation, and execution of clinical development programs that support the LifeLens growth strategies.


    This person is a key member of the leadership team and will work cross-functionally within LifeLens and with external partners to ensure evidence-generation programs meet product development (and financial) milestones and requirements for regulatory submissions and market access, reimbursement, and commercialization of the LifeLens Technologies platform.

    This is an on-site position. Some travel may be required.


    Essential Functions:


    Leads the design of Clinical Projects including development of trial protocols and budgets, CRO/vendor selection, investigator/site selection, data collection and analysis plans, and publication strategies.

    Develops collaborative relationships with key investigators and clinical thought leaders.

    Oversees and attends clinical advisory boards and investigator meetings.
    Guides and supports operational trial management activities including budgets and timelines, CRO/vendor oversight, site monitoring, and conflict/risk mitigation.

    Ensures trial operations adhere to clinical protocols and terms of the study and are performed in line with LifeLens' Standard Operating Procedures (SOPs) and Good Clinical Practice (GCP).

    Contributes to and critically reviews regulatory submissions and pre- / post-submission interactions.
    Provides Clinical Program updates, including trial status/metrics, budget, accomplishments, and risks to Senior Management and other relevant stakeholders.

    Collaborates with senior management to ensure alignment of resources and budgets across clinical programs by evaluating timelines and prioritizing tasks.

    Leads and/or participates in continuous improvement initiatives to ensure SOPs for clinical development and execution facilitate effective clinical research programs and are compliant and evolving with clinical/medical regulations and industry standards.

    Travels as necessary to facilitate and support clinical trials and investigator interactions


    Competencies:
    Bachelor's degree in a scientific or health-related field required.
    Master's degree in a scientific or health-related field is preferred.
    PMP certification preferred.
    Minimum of 10-12 years of medical device clinical research experience, including on-site monitoring experience.
    Minimum of eight to ten years of experience in the management of clinical trials as a project manager or other relevant experience at a med- tech/pharmaceutical/biotech

    company or CRO.
    Minimum of four to six years of prior supervisory experience required.
    Expert knowledge of FDA regulations and US 21 CFR 820 and EU 13485 quality system requirements required
    Strong ability to prioritize tasks and keen attention to detail.
    Excellent written communication, and presentation skills.
    Demonstrated leadership and project management skills.
    Proven ability to work on multiple projects in a fast-paced environment.

    Strong interpersonal skills with the ability to interact effectively with all levels of associates both within and outside the organization.


    Benefits:
    Health Insurance
    Dental/Vision Insurance
    Paid Time Off
    Flextime
    Stock Option Incentive Plan

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