Colin Irwin
Clinical Operations Manager @Cochlear
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WORK HISTORY
Clinical Operations Manager @Cochlear
Basel, CH
Responsible for operational execution of all clinical investigations in EMEA, including team management of: • Clinical investigation execution • Study quality compliance • Initiation, on-going monitoring and close-out • Data management • Standard Operating Procedures (SOPs) improvement projectTeam lead - planning, execution and implementation - Cochlear\'s Clinical Affairs stream for the EU Medical Device Regulation 2017/745. Areas include: Clinical Evaluation, Clinical Investigations, Post Market Clinical Follow-up and Post Market Surveillance, along with reporting requirements for Summary of Safety and Clinical Performance, and Periodic Safety Update Reporting.
EDUCATION
University of Sydney
BE, Electrical
University of Sydney
BSc, Computer Science
Goethe Institute
Zertifikat Deutsch, German Language and Literature
Penn State University
Master of Applied Statistics, Statistics
SKILLS
ABOUT COLIN IRWIN
I\'ve worked in the medical device field for the past 20 years, as an engineer, engineering team leader, research / clinical studies specialist and more recently clinical operations manager.Notable recent achievements include: • Creation and execution of customer engagement \"Science and Research Seminar\" program • Implementation of online project management system for Investigator Initiated ResearchWhat are my strengths? • An ability to see the bigger picture and thus determine how to execute successfully. • People and project management skills. • Knowledge of clinical investigation requirements - MDR2017/745, ISO14155, ISO13485 and ISO14971. • IT systems to use - what\'s effective, what\'s not and how to meet in between.For something different, I\'m currently studying for a Masters of Applied Statistics at Penn State University.Contact me if you have an opportunity.Specialties: Clinical investigations, EU regulatory framework, project management, software development and hot sauce.
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