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Online Resumes with "oracle clinical"
Over 20 years in the Pharmaceutical Industry which has included Regulatory, Safety, Medical Encoding, Data and Quality Review Management. As a nurse by profession I have utilize my expertise in Case processing; Investigational and marketed products across industry standards. I have held key roles in the day to day functioning of the Clinical Safety and Pharmacovigilance Departments.
SUMMARY * 5.4 years of experience in analyzing and gathering data for Clinical trials. * Proficient in defining and validating protocols for clinical studies and handling trial responsibility throughout the data-management lifecycle. * Work closely with Oracle Clinical developers on the design, testing and implementation of study databases. * Extensive experience in trial start-up, trial conduct, database lock and Post data...
Tags for this Online Resume: Data Entry, Management, Protocol, Cancer, Immunology, Infectious Diseases, Query, Team Lead, Data Management, Data Manager, oncology, phase, clinical, trial, protocol, gcp, pharmaceutical, ich, OC database, OC-RDC-TAO database
SUMMARY * 23 years as a Clinical Data Management working for the following companies: Novartis, PRA International, Abbott, Covidien, Ingenix (i3), Ortho Clinical Diagnostics, Octagon Research Solutions and Pharmanet i-3. * 20+ years' experience of team leadership working with: Data Manager, Clinical Data Coordinator (CDC), Data Entry Personnel, Biostatisticians, Programmers, Investigators and Clinical Research Associates (C...
SUMMARY Dynamic, results oriented global operations leader with diverse experience in a Clinical Safety and Clinical Data Management matrix environment. Experience as a change agent for enhancing performance and streamlining processes. Articulate, energetic and innovative individual with excellent interpersonal and individual development skills who thrives on challenges and operating outside his comfort zone.
I have extensive experience in writing clinical and regulatory documents in the Pharmaceutical industry which include regulatory and safety I have completed medical encoding (MeDRA), data and quality review management. My past experience included responsibilities for preparing safety sections within key documents such as Investigations Brochure, clinical study reports, writing safety narratives to be included in final stud...