Glamora Samuels, MD Avatar

Glamora Samuels, MD

Medical Monitor/Medical Director
  • Medical Professional with extensive phase I –IV clinical research experience
  • Thorough knowledge of GCP, clinical trial design, regulatory process and global clinical development process
  • Well versed in all areas of pharmacovigilance standards, SOP GCP practices, theory and Implementation of clinical development program based on strong medical and scientific principles.
  • Medical review of ICSRs, SUSARs, SAEs and IBs
  • Over five years of medical monitoring, highly skilled in executing, planning and managing clinical trials in various therapeutic area: Oncology, Immune-Oncology, Hematology/Multiple Myeloma Pulmonology/Respiratory, and Endocrinology (Diabetes) Infectious diseases, GI, General surgery, Rare Diseases, Neurology, Cardiovascular, and Inflammation.
  • Serves as a medical monitor contact in study protocols and participates in real time monitoring of patients eligibility assessment, study design questions accrual and safety review data review. Responsible for assessment and reporting of serious adverse events per cooperate protocol on which assigned.Participated.in the development of clinical outsourcing specification to facilitates bid templates and selection of CROs
  • Clinical development experience includes concept through approval drug development expertise inclusive of development strategy, protocol design and implementation, medical monitoring, results interpretation and reporting, and NDA filing of registration trials leading to approvals
  • Previous solid experience in clinical development of check point inhibitor monoclonal antibodies for solid tumors and hematological malignancies
  • Participated and made significant contributions to clinical contents of filling preparation of marketing authorization application.
  • Overall responsibility for leading clinical studies ,team ,monitoring overall Integrity and review interpretation and communication of data pertaining to safety and efficacy and safety of product.
  • Experience in clinical development programs and global drug submission e.g. New drug application (NDA)

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