Clinical Quality Associate Lazio

Clinical Quality Associate
Roma
Lazio, Lazio

Meditrial is a full-service clinical research organization (CRO) dedicated to clinical trial conduct, medical education, regulatory affairs, and market access.

Our offices are located in Germany, Italy, Switzerland, the UK, and the United States, and our teams rely on digital tools to work collaboratively to achieve shared goals.

Since 2008, Meditrial has delivered unparalleled outcomes for innovators.

Our successful track record supporting the life sciences industry manufacturers in all phases of clinical development puts us in a prime position to seize the opportunity to emerge as a leader in digital technology with the promise that it will enhance and alleviate the clinical trial and participant burden.

Through our work, the patient and innovator are empowered with data and insights across the lifecycle of product development and market penetration, changing the paradigm of care towards understanding and value.

We have the ability to transcend the current landscape with "smart" technology-enabled data collection tools and insights.

Meditrial offers the highest level of expertise across multiple therapeutic areas.

We are passionate about our mission to support the innovation and development of better therapies in compliance with solid ethical standards.

Our commitment has resulted in excellent results for business growth by creating stability and opportunities for employees and collaborators.

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

Employment Type: Full-time

Job Functions: Clinical Quality Affairs

Location: Meditrial, Via Po 9 Rome, Italy

Workplace: Office-based

The Clinical Quality Associate provides support to all organizational levels of the CRO to operate in compliance with internal, national, and international regulations in every aspect of clinical development on a Quality Management System basis.

The ideal profile would be practical-minded and should have life science and quality expertise and a background in clinical operations.

Responsibilities: Support the clinical team for the management of the entire Clinical Trial, also regarding the EDC System and CTMS, by guaranteeing the correct application of the Quality System Procedures (SOPs);Support the clinical project team in assessment and management of clinical trials with medical devices (mainly in the cardiovascular therapeutic area) according to current regulations;Collect, review, draft, and track regulatory and investigator documents required for submission to the Competent Authorities and Ethics Committee; maintain, update, and file document trackings;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;Support for creation and maintenance of reports, charts, spreadsheets, documents, and presentations;Setup, maintenance, and update of files and records; Qualifications: Education: Bachelor's degree, Master is a plus;

Experience in the life science field and Quality Management;

Languages: Proficiency in Italian and English (a third language would be a plus);

Proficient in Microsoft Office (MS Outlook, MS Word, MS Excel, MS PowerPoint);

Excellent communication, planning, and organizational skills;

Demonstrated ability to handle multiple competing priorities.

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