Clinical Quality Associate

3 settimane fa

Lazio, Italia Meditrial Europe Ltd. A tempo pieno

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, UK, United States and our teams rely on digital tools to work collaboratively to achieve shared goals.
Since 2008, Meditrial delivers unparalleled outcomes for innovators.
Our successful track record supporting the lifescience 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 highest level 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 level of the CRO to operate in compliance with internal, national and international regulations in every aspect of clinical development on a Quality Management System base.
The ideal profile would be practical-minded and should have life science and quality expertise and a background in clinical operations.
**Responsibilities**:
- Supporting the clinical project team in assessment and management of clinical trials with medical devices (mainly cardiovascular therapeutic area) according to current regulations;
- Collecting, reviewing, drafting and tracking regulatory and investigator documents required for the submission to the Competent Authorities and Ethics Committee; maintaining, updating and filing document trackings;
- Performing 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;
Qualification
**Education**: Bachelor's degree, Master is a plus;
Experience in life science field and Quality Management;
**Languages**: proficiency Italian and English (a third language would be a plus);
Proficient in Microsoft Office (MS Outlook, MS Word, MS Excel, Ms Power Point);
Excellent communication, planning and organizational skills;
Demonstrated ability to handle multiple competing priorities.

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