Asuncion Nalevanko - Executive Director Resume Simple
To obtain a position in a reputable company that will allow me to utilize my skills and experience to provide quality patient care. I am a highly motivated individual with a strong work ethic, and a commitment to excellence.
  • management, organization, ich, iv, marketing, audits, manufacturing, efficient, compliance, training, fda, reporting
  • management, ich, monitoring, clinical research, fda, clinical trial, responsible, research, implementation, clinical
  • 2017-12-252017-12-25

    Executive Director


    • Responsibilities included: Compliance with all regulatory requirements, including but not limited to, training, supervision, and documentation of clinical and non-clinical staff.
    • Conduct clinical operations, including planning, coaching, training, and supervising all regulatory and compliance activities, as well as ensuring that the customer service is provided.
    • Managed clinical and regulatory compliance for the FDA and EU region. Provided support for the construction and development of the clinical research and marketing.
    • Develop and maintain clinical documentation, including but not limited to, the development of quality assurance plans, internal audits, and regulatory compliance.
    • Management of clinical trial teams and ensured regulatory compliance with the global regulatory requirements. Developed and implemented quality assurance programs, including the development of the CAPA plan.
    • Manage clinical documentation of all regulatory filings, including but not limited to, regulatory compliance, GMP, and manufacturing.
  • 2017-12-252017-12-25


    The Old Spaghetti Factory

    • Clinical research project Manager responsible for the development and implementation of the FDA regulated monitoring system. Conducted site visits to ensure compliance with regulatory requirements.
    • Review and approve clinical trial management documents (e.g. And FDA approved) for approval. Prepare and submit reports for submission to the sponsor.
    • Experienced in performing clinical studies, including but not limited to, data review, EDC, SAE reconciliation, query resolution, and investigational product accountability.
    • Responsible for the preparation of study protocols, informed consent forms, and case report forms. Conduct and document clinical trial data.