Company Overview:
Meditrial is a dynamic and rapidly growing multinational company specializing in providing clinical and regulatory services to medical device companies in the USA and Europe. With a commitment to excellence and innovation, we empower our clients to navigate complex regulatory landscapes and bring life-changing medical devices to market efficiently and compliantly. Our dedicated team of experts ensures the highest quality standards and compliance with regulatory requirements.

Position: Clinical Quality Associate:
Industry: Lifescience Industry: Pharma, Medtech, Digital Health

Employment Type: Full-time

Job Functions: Clinical Affairs

Location: Meditrial Europe, Zug, Switzerland

Workplace: Office based

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 the 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 and German (a third language considered a plus);
• Proficient in Microsoft Office (MS Outlook, MS Word, MS Excel, Ms Power Point);