Raphael Freitas
Clinical Scientist (Oncology) - Performing Medical Monitoring Activities for Merck @ICON plc
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WORK HISTORY
Clinical Scientist (Oncology) - Performing Medical Monitoring Activities for Merck @ICON plc
Clinical point of contact for scientific issues/questions for internal and external stakeholders (e.g, IRB, sites) • Perform Medical Monitor activities, including the development of the Medical Monitoring Plan (MMP) and review of SAE reports • Supports SAC, DMC, adjudication committees • Protocols/amendments – collaborates with MW, participates in DRC/DVC/PRC/FORCe • Authors protocol clarification letters • Contributor to study specific documents (e.g, SMP) • Reviews/updates informed consent • Provides scientific input to SM for data management activities (e.g, EDC, DRP, CRFs) • Monitors data issues requiring clinical input • Monitors central lab reports and other external data for safety and critical values • Provides clinical specifications to SM to support interactions with external vendors (e.g, IVRS, ePRO)• Prepares scientific slides, attends and presents protocol information at Investigator Meeting • Reviews specs, initiates allocation (randomization) request form (ASRF) and approval schedule in CSGS (allocation schedule generation system)• Coordinates planning of lab, bio specimens and imaging specifications • Co- authors newsletters with SM • Participates in Database lock activities • Collaboratively plans CSRs, CTDs/WMAs with MW • Supports publications/presentations as needed • Reconciles and review all protocol deviation classifications in SPECTRUM • Assesses and prepares protocol violator/deviation list for CSR • Collaborates with MW to develop trial results communication for investigators • Provides scientific assessment for Operational Reviews • Supports SM/MW activities as needed to achieve Clinical Trial Team (CTT) deliverables.
EDUCATION
Rushford Business School
Advanced Professional Certificate in Managerial Skills
Universidade Federal de São Paulo
Anesthesiologist
Universidade Federal de São Paulo
Doctor of Medicine (MD)
McGill University
Graduate Certificate in Health Services Management
ABOUT RAPHAEL FREITAS
Dr. Freitas is a trained physician with a strong medical and research background. Dr. Freitas worked as an anesthesiologist at the São Paulo Hospital, the largest teaching hospital in Brazil and the reference in highly complex procedures, where he also used to be a supervisor and mentor for medical residents. His medical research in different areas led him to publish in important scientific journals. While working for the MUHC research institute, an international research powerhouse with a worldwide reputation, Dr. Freitas provided clinical research and medical expertise in phases II and of oncology clinical trials. Dr. Freitas worked closely with Investigators to review safety data and to ensure compliance with the currently approved protocol and the study participants’ safety under the established regulations in clinical research (i.e. ICH-GCP, Health Canada Division 5, FDA-CFRs) and research ethics. Dr. Freitas worked as a medical monitor at Innovaderm and was responsible for phase studies in dermatology (pruritus, acne, atopic dermatitis, alopecia areata, HS, ichthyosis, generalized pustular psoriasis) for adults and pediatric population in North America and Europe. Dr. Freitas has been working at ICON CSSM management team (on assignment at Merck) as a Clinical Scientist in Oncology and is accountable for the clinical/scientific execution of the clinical protocol.
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