Shawn Ditommaso Email & Phone Number

Boston, Ma, Us

Boston, Ma, Us

Cambridge, Massachusetts, United States

Manage and lead the day-to-day operations of a global tuberculosis treatment shortening trial, including vendor management and budget tracking to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.Lead development of or provide input to study-related documents including protocols, informed consent forms, monitoring plans, EDC/case report forms, study, lab and pharmacy manuals, data… Show more Manage and lead the day-to-day operations of a global tuberculosis treatment shortening trial, including vendor management and budget tracking to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.Lead development of or provide input to study-related documents including protocols, informed consent forms, monitoring plans, EDC/case report forms, study, lab and pharmacy manuals, data management plans, Clinical Study Reports, etc.Oversee study-related activities including site identification and selection, enrollment models, clinical supply planning and drug supply, investigator and vendor meetings, and development of systems.Receiving continued exposure and training with Pharmacovigilance department to better understand drug safety surveillance and regulatory reporting approaches for clinical trials. Show less

Cambridge, Massachusetts, United States

Assisted with preparation of all external and internal documentation for a tuberculosis treatment shortening study, to ensure documentation is completed in accordance with GCP/ICH regulatory requirements and with the study protocolLiaised with CROs and other clinical vendors to ensure deliverables were met and communication was efficient and effective Assisted in clinical operations initiatives including creation and updating of standardized clinical trial tools, process and… Show more Assisted with preparation of all external and internal documentation for a tuberculosis treatment shortening study, to ensure documentation is completed in accordance with GCP/ICH regulatory requirements and with the study protocolLiaised with CROs and other clinical vendors to ensure deliverables were met and communication was efficient and effective Assisted in clinical operations initiatives including creation and updating of standardized clinical trial tools, process and procedures Show less

Lexington, Massachusetts, United States

Previously reported to Clinical Project Manager on assigned clinical programs and protocols in order to manage clinical trials ensuring studies are conducted efficiently, on time, within budget and in accordance with established SOPs, applicable regulatory requirements, and Good Clinical Practice (GCP)

Lexington, Massachusetts, United States

Used a strong application of GCP and management practices, principles, theories, and concepts in specialized area of responsibility, alongside working knowledge of related disciplines (eg: Medical, Biostatistics, Data Management, Regulatory Affairs, CMC/Manufacturing, Quality, Legal, Compliance, Procurement).

Quincy, Massachusetts, United States

Associate Site Lead of MADPH COVID-19 mass vaccination clinic at Gillette StadiumVaccinator at MADPH COVID-19 mass vaccination clinic at Gillette StadiumTester on Massachusetts Department of Public Health (MADPH) COVID-19 Mobile Strike Team

Needham, Ma

Previously reported to Chief Medical Officer (CMO) in order to support clinical, monitoring, and regulatory operations of Phase III Immunotherapy clinical research trials for the treatment of Localized Prostate Cancer.

Previously responsible for organizing all on-site aspects of medical and pharmaceutical research studies per protocol requirements.

Greater Boston Area

Performed clinical services including, escorting patients to treatment rooms, prepared patients for examinations, recorded vital signs, administered EKGs, collected blood sugar readings using POCT, and entered clinical information into their electronic medical record.

Greater Boston Area

Facilitated communication across Medical and Surgical floor by delegating tasks to medical staffincluding nurses, physicians, and surgeons.

Master Of Public Health - Mph, Epidemiology & Biostatistics

Bachelor'S Degree, Premedical And Health Studies