Position: Clinical Quality Associate

Responsibilities

• Aid the Clinical Quality Manager with various administrative tasks.
• Support the clinical team in managing clinical trials, including the EDC System and CTMS as per SOPs.
• Assess and manage clinical trials involving medical devices, particularly in the cardiovascular therapeutic area, adhering to current regulations.
• Collect, review, draft, and track regulatory and investigator documents required for submission to Competent Authorities and Ethics Committees.
• Maintain, update, and file these documents.
• Perform administrative tasks such as word processing, collecting study documents, managing relations with Study Investigators, and updating internal progress reports during study start-up activities.
• Notify SAEs to Competent Authorities and Ethics Committees.
• Provide support for the creation and maintenance of reports, charts, spreadsheets, documents, and presentations.
• Establish, maintain, and update necessary files and records.

Qualifications

• Bachelor’s degree, Master’s degree preferred; 2+ years of experience in life sciences and Quality Management.
• Proficiency in oral and written English; additional language skills are a plus.
• Expertise in using Microsoft Office applications (MS Outlook, MS Word, MS Excel, MS PowerPoint).