Daniel M. Email & Phone Number

São Paulo, São Paulo, Brazil

Study planning and development from early study setup to finalization.Development and review of clinical study documents like protocols, protocol amendments, statistical analysis plan, informed consent form (ICF), Study monitoring plan, CRF Completion Guidelines, and data management plans among others.Author of the Medical Data Review plan.Liaison with data management and programmes to generate electronic data capture (EDC) and case report forms (CRF).Focus on Medical data review to ensure data quality and consistency with query generation and resolution.Review of serious adverse event (SAE) reports.Conduct, prepare and present safety reviews of study databases to identify trends and potential safety issues.Point-of-contact for questions/inquiries from sites, investigators and other team members.Protocol deviation identification and management. Mentoring activities of junior clinical scientists.Review and validation of safety-related sections of clinical study reports (CSR).Liaison with medical writers and external partners to develop clinical narrative plans and conduct clinical narrative preparation/review. Cross functional collaboration with several internal and external partners to ensure study design and conduct under the principles of Good Clinical Practice (GCP) in accordance with health authorities expectations.

São Paulo, Brazil

Medical review for individual case safety reports (ICSR) from different sources (clinical trials, literature, post marketing studies and post marketing spontaneous adverse event reports) to ensure timely report distribution to internal and external stakeholders.Review all AEs and SAEs to ensure that all events, symptoms and clinically significant information are adequately collected.Ensure that reported event terms are correctly coded with MedDRA and analyzed for expectedness according to Reference Safety Information (RSI) or Investigator's brochure (IB) as applicable.Case narrative writing and review with assessment of adverse events (AE) and serious adverse events (SAE) providing company causality assessment based on the analysis of possible alternative explanations. Managment of ICSR with follow-up (FU) requests and FU query generation as well as query posting in clinical databases when applicable. Experience with safety systems and databases like Argus, MedDRA coding tools, Who Drug dictionary and clinical databases like Rave.Experience with analysis and reporting of SUSAR/IND reports (including unblinding).

São Paulo Area, Brazil

Clinical practice as clinical neurologist in an outpatient setting with focus on the care of elderly patients.

São Paulo Area, Brazil

Clinical practice in hospital setting with focus on care of hospitalized patients.

São Paulo Area, Brazil

Clinical practice as clinical neurologist with focus on the care of patients with Multiple Sclerosis and Neuromyelitis Optica.

São Paulo Area, Brazil

Clinical practice as clinical neurologist with focus on the care of patients with neuromuscular disorders.

São Paulo Area, Brazil

Clinical practice in general neurology in hospital and outpatient setting.

São Paulo Area, Brazil

Clinical practice in general neurology in an outpatient setting.

Doctor Of Philosophy - Phd, Immunology, Post Graduation

Master'S Degree, Immunology, Post Graduation

Medical Residency, Neurology Residency Program, Post Graduation

Medical Residency, Internal Medicine Residency Program, Post Graduation

Medical Doctor, Medicine, Graduate