Mike Dioguardi

Sr. Clinical Project Manager @ IQVIA

About

Over twenty years of clinical research experience in such therapeutic areas as anesthesia/sedation, hematology, skin infection, hemostasis, depression, Alzheimer’s disease, and acute pain management. Has provided a leadership role in bringing multiple medical devices to market and recruiting key opinion leaders. Thirteen years’ experience in project management, training, and resourcing. Strong statistical and data management skills. Specialties: Medical Device product development, working in cross-functional teams, and post-marketing research

Country

United States

City

Medford

Industry

Research Services

Skill

Clinical Research, Sop, Protocol, Therapeutic Areas

Experience

senior clinical project manager

hemanext

2015-10 - 2017-7 · 1 yr 10 mos

Responsible for the design and execution of clinical trials for CE marking and FDA clearance. Authored and implement SOPs for clinical research. Represented the research team for routine product development meetings. Act as a liaison between Product Development and the blood lab for preclinical research internally, and manages site relationships for external investigator initiated trials.

senior clinical research associate

haemonetics

2010-6 - 2012-4 · 1 yr 11 mos

Responsible for all clinical trials run in the US as both CRA and CPM. Responsible for tracking and maintaining all investigator initiated trials worldwide. Authored SOPs, Protocols, and Statistical Analysis Plans. Coordinated vendor selection for EDC and CTMS systems. Recognized and awarded for leadership through a difficult FDA audit in which no 483’s were issued.

director, research and clinical affairs

hemanext

2017-7 - Present · 9 yrs 3 mos

clinical project manager

haemonetics

2011-1 - 2015-9 · 4 yrs 9 mos

Responsible for the design and execution of key clinical trials in Throboelastography, Cell Salvage, and Whole Blood donation. Managed Investigator Initiated trial program. Member of multidisciplinary teams to set corporate strategy for increased revenue in cell salvage and IVD products. Strong regulatory knowledge and representative for clinical research team at pre-IDE meetings with FDA. Responsible for hiring and management of various contract staff.

clinical research associate

abt associates

2008-8 - 2010-4 · 1 yr 9 mos

Performed source document verification, clinical review of CRFs to ensure accuracy and integrity for the Registry projects. Authored monitoring plans and assisted in the revision of key SOPs. Assisted with clinical operations portions of proposals. Established and maintained a good working relationship with clients and study site personnel.

senior clinical research associate

aspect medical systems

2001-4 - 2008-7 · 7 yrs 4 mos

Experience and exposure to all aspects of monitoring, to include site selection, initiation, monitoring, and close out visits. Acted as RC for in-house research. Responsible for maintaining a large database and performing data extraction, verification, and analysis. Managed multi-center trial on pediatric anesthesia with 2000 patients collected. Authored protocols, consents, product development plans, and final reports. Acted as key member and signatory in product realization process and managed multi-center product evaluations with tight deadlines. Responsible for compiling quarterly quality report and tracking resources. Direct supervisor of 2-4 Clinical Research Assistants.