• Clinical Project Manager

    Posting Date 4 months ago(7/27/2018 8:52 AM)
    Requisition ID
    2018-4961
    Job Location(s)
    West Lafayette IN United States
    Position Type
    Full Time
    Company
    Cook Research Inc.
    Category
    Clinical
  • Overview

    The Clinical Project Manager at Cook Research Incorporated is responsible for the study-level management (execution and closeout) of clinical studies, including clinical study planning, performance analysis, and oversight, while ensuring cross-functional teams are appropriately informed and coordinated to execute the clinical study in order to meet company objectives.

    Responsibilities

    • Develop and maintain a working knowledge of local and global regulatory requirements and standards (e.g., FDA CFR, ISO 14155, ICH GCP, EU MDR) that impact clinical studies

    • Develop and maintain a working knowledge of study specific and general disease pathology

    • Work closely with Clinical Management and Clinical Science to determine priorities and to ensure that appropriate resources are available to achieve study objectives and milestones

    • Develop and coordinate clinical study-related documents, plans, and training materials (e.g., CIP, IB, CRF Specifications, Study-specific IC Template, Progress Report, Training Plan, Audit Plan, Monitoring Plan, Clinical Study Overview Presentation)

    • Provide study oversight and track study progress; work with the appropriate clinical study team members and/or management to ensure study activities are being conducted in a timely manner and comply with quality system procedures, applicable regulations and standards, and clinical systems

    • Maintain effective communication with cross functional teams and stakeholders

    • Where appropriate, prepare and submit regulatory applications for the clinical study

    • Lead efforts, drive the content, and collaborate with Logistics Management for external meetings (e.g., RC, Investigator, SIM)

    • Lead efforts and plans for internal meetings (e.g., CRF retreat, Kickoff, clinical project)

    • Prepare and provide study materials (e.g., investigator file, pocket cards, IRB/EC packet) to CRAs for distribution to clinical sites

    • Train the internal clinical study team, including vendor CRAs

    • Ensure the clinical study is registered and maintained on a public database

    • Work closely with the CRA to coordinate site visits

    • Review reimbursement reports

    • Participate in site selection and PI changes during the clinical study

    • Manage vendors at a study level, as needed

    • Ensure clinical systems (e.g., EDC, CDMS) are accurate and up to date

    Qualifications

    • Bachelor’s degree (scientific, health, or business related field preferred), plus significant relevant experience is required

    • Master’s degree with demonstrated research or project management background is preferred

    • Previous experience in the conduct of medical device/drug clinical studies (including a knowledge of applicable regulations and standards) is preferred

    • Proven ability exercise sound judgment in independent decision making

    • Conscientious, influential person with an outstanding work ethic and strong personal discipline

    • Ability to interact with physicians, scientists, and company executives in a professional and personable demeanor in a variety of settings and interactions

    • Willingness and capability to handle multiple projects and responsibilities

    • Excellent organizational, leadership, and problem-solving skills

    • Excellent computer, written, and verbal communication skills

    • Ability and desire to work in a collegial team atmosphere; including communicating and working constructively with colleagues

    • Sufficiently assertive to deal with confrontational situations

    • Experience in writing technical documents

    • Experience working in a team settings

    • Willingness and ability to travel as needed

    • Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

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