John Capers - Senior Project Manager Resume Simple
To obtain a position in the field of pharmacy that will allow me to utilize my skills and knowledge to provide the highest level of care to patients.
  • management, clinical trials, ich, regulatory affairs, coordination, filing, design, payments, gcp, contracts, database, fda, safety, maintenance, clinical
  • management, office, clinical trials, clinical research, ich, responsible, research, data management, quality assurance, quality, planning, safety, gcp, clinical
  • 2017-12-252017-12-25

    Senior Project Manager

    Duval County Public Schools

    • Design, negotiate, and maintain regulatory contracts for the maintenance of the study Master file. Ensure that all research and regulatory documents are filed and submitted to the FDA.
    • Collects and reviews regulatory documents for submission to regulatory agencies, including: But not limited to, briefing documents, clinical trial material, safety database, and other pertinent information for the purpose of research.
    • Ensure regulatory compliance with research protocols, IRB, and other regulatory documents. Review and approve study protocol and case report forms.
    • Ensure regulatory compliance with the research protocol, GCP, and the applicable regulatory requirements. Coordination of the study site and related documents.
    • Monitor regulatory Affairs for trials and ensure that all trials are conducted in accordance with the applicable regulatory requirements and ICH guidelines.
    • Oversee data collection and management for research projects. Manage and track study payments and milestones. Identify and resolve issues.
  • 2017-12-252017-12-25

    Program Manager

    Andy Frain Services

    • Ensures that all research projects are conducted in compliance with the quality assurance and GCP guidelines. This includes but is not limited to: Study management, data management, and regulatory document.
    • Participated in the planning and execution of clinical trial activities for the FDA and other regulatory agencies. Conducted research and development of new trials.
    • Trained and supervised new research associates in the use of the clinical trial in accordance with FDA regulations and ICH guidelines.
    • Worked with the FDA and the research team to ensure the overall quality and safety of the office. Responsible for all aspects of the study.
    • Developed and implemented a robust data collection process for the clinical trials of the National Institute of excellence (NIH).
    • Manage and oversee the clinical trial start-up activities including: Site selection, initiation, interim, and close-out visits.

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