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.
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.
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.