Industry: Lifescience Industry: Pharma, Medtech, Digital Health
Employment Type: Full-time
Job Functions: Clinical Affairs
Location: Meditrial UK Ltd. London, United Kingdom
Workplace: Office based
Benefits: Discussed confidentially during dedicated meeting
To learn more: www.meditrial.net
The Clinical Quality Associate provides support to all organizational levels to operate in compliance with international regulations in every aspect of clinical development and clinical trial conduct. The ideal profile would be practical-minded and should have lifesciences and quality expertise and a background in clinical operations.
Responsibilities
· Assist Clinical Quality Manager with various administrative tasks
· Support the clinical team for the management of clinical trials including the EDC System and CTMS as defined by the Quality System Procedures (SOPs);
· Support the clinical project team in assessment and management of clinical trials with medical devices (mainly cardiovascular therapeutic area) according to current regulations;
· Collect, review, draft and track regulatory and investigator documents as required for the submission to the Competent Authorities and Ethics Committee; maintaining, updating and filing documents;
· Perform administrative tasks required during study start-up activities (e.g. word processing, collecting study documents, relation management with Study Investigators, updating internal progress reports);
· SAE Notification to Competent Authorities and Ethics Committee.
· Provide support for creation and maintenance of reports, charts, spreadsheets, documents and presentations;
· Establish, maintain and update files and records as needed;
Skillset & Qualifications
· Education: Bachelor’s degree, Master is a plus;
· Minimum 2 years experience in life science field and Quality Management;
· Languages: proficiency in oral and written English (a second language would be a plus);
· Proficient in Microsoft Office (MS Outlook, MS Word, MS Excel, Ms Power Point);