Yverdon-les-Bains Posté il y a 7 jours

To strengthen our Clinical Affairs team in Switzerland, we are currently looking for a

Senior Clinical Trial Specialist

Job description:
The Senior Clinical Trial Specialist (Clinical Research Specialist) supports the department by coordinating and executing sponsored clinical studies, from planning activities to archiving of study documentation. Its main role is to set-up clinical investigations for Symbios medical devices products, according to EU Medical Device Regulation, ISO 14155 and other applicable regulations.

Responsibilities:
Support operational execution of global clinical trials following ISO 14155 and GCP requirements
Ensure clinical site management and monitoring activities
Track, collect and maintain audit-ready trial documentations, including regulatory submission and study specific essential documents. Maintain compliant clinical trial documentation and quality assurance (TMF)
Ensure operational support of clinical study teams including the follow up on open action items
Support the Clinical Affairs Manager to allow timely responses to Competent Authority (in Belgium, France and Germany), physicians, other requesters for Clinical Studies topics
Develop, implement, and maintain global Symbios database on post-marketing studies, including case report form (CRF) design, data validity check specifications
Review clinical investigation protocols and other clinical research documents for identification of data collection needs and compliance with applicable regulations
Support data analysis and statistical activities for publication purposes
Working closely with the Clinical Affairs Manager to define project targets for external partners and ensure work is documented within the contracted project scope
Development and implementation of Clinical Monitoring Plan
Coordination and oversight of daily operations of the clinical monitoring team (external partner)
Management of project milestones and proactively address deficiencies
Management of CRA performance (external partner)

Qualifications & Required Knowledge, skills & Experience:
Bachelor’s or Master’s degree in Medical Technology, Life Sciences, Clinical Affairs (or equivalent work experience in similar function)
5-7 year’s experience as Trial/Study manager or strong background as Lead CRA
1-2 years of experience in a medical device field (MDD/MDR requirements) specially with regulatory, quality and clinical affairs
Good knowledge of the ISO 14155: ICH GCP requirements
Ability to work autonomously, exercise daily judgment based on above regulatory/clinical knowledge
Result oriented and demonstrated organizational/planning skills based on team priority
Fluent in English, French and German
General Computer skills (PC, Microsoft Word/Excel/PowerPoint, Outlook/Teams)
Ability to travel occasionally in Europe