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Clinical trial manager for medical device development

Sligo
beBeeQualityManagement
Clinical trial manager
Posted: 12 September
Offer description

Senior Research Manager for Clinical Trials An exceptional opportunity to manage clinical study activities as part of a clinical team, supporting the development of innovative medical devices in line with international standards and quality management systems. Job Description: * Coordinate clinical investigation activities, maintaining accurate study product logs and inventory records * Work collaboratively with site staff, consultants, and teams as needed * Order preclinical/clinical supplies when required * Assist in designing and writing protocols for preclinical & clinical studies * Conduct literature reviews and MAUDE searches for evaluations * Create and update Certificates of Expertise and Certificates of Examination Required Skills and Qualifications: * Strong knowledge of Quality Management Systems, Good Clinical Practice, and Good Laboratory Practice for medical devices and clinical studies * Understanding of Class III device regulations in EU, US, and globally (ISO 14155 & EU MDR 2017/745) * Minimum 5 years' experience in clinical studies for medical devices ideal * Cardiovascular experience an advantage * Fluent in English (and local language if different) * Familiarity with device development from pre-clinical to commercial stage * Knowledge of GCP in US & EU * High attention to detail * Awareness of regulations for feasibility, pivotal & post-market studies, and ability to adjust oversight accordingly Key Responsibilities:

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