Summary:
• 20 plus years experience in the pharmaceutical, medical device, and CRO industries
• 10 years in National Management and Training
• Knowledgeable in clinical trial operations from feasibility through to closeout.
• Experience in FDA regulations 21 CFR, Parts 11,50,54, and 56
• Skillful in maintaining the regulatory binder, which houses essential documents such as1572, source
documents, DOA, training Logs, ICF, SAE forms, Financial Disclosures, Subject Enrollment &
Identification Logs, Case Report Forms (CRF), Procedure manuals, Standard Operating Procedures
(SOP), Site Visit Logs, Correspondences, Trial Master Files (TMF) and other Investigator Site File (ISF)
document.
• 2 years Phase 4 research projects
• Pharmacovigilance Leadership
• Clinical Research Site Activation Coordinator
Specialties:
Sales, Account Management and Project Management. Extensive medical knowledge and experience with multiple therapeutic areas. Proven track record in both the large and small pharma environments and extensive experience with CRO’s. Expert with contract negotiations with health systems at CFO and CEO level.Summary: • 20 plus years’ experience in pharmaceutical, medical device, and CRO industries • 10 years in National Management and Training • Knowledgeable in clinical trial operations from feasibility through to closeout. • Experience in FDA regulations 21 CFR, Parts 11,50,54, and 56 • Skillful in maintaining the regulatory binder, which houses essential documents such as1572, source documents, DOA, training Logs, ICF, SAE forms, Financial Disclosures, Subject Enrollment & Identification Logs, Case Report Forms (CRF), Procedure manuals, Standard Operating Procedures (SOP), Site Visit Logs, Correspondences, Trial Master Files (TMF) and other Investigator Site File (ISF) document. • 2 years Phase 4 research projects • Pharmacovigilance Leadership • Clinical Research Site Activation Coordinator Specialties: Sales, Account Management and Project Management. Extensive medical knowledge and experience in More...