: Gore is a materials science companyfocused on improving lives through discovery, product innovation and rewardingcareers for our Associates.
About the Industry: Saving lives and improving the qualityof life for patients is at the core of everything we do. This meaningful workgives purpose to our lives and inspires us to create solutions that make adifference in the lives of others. Learn more at gore.com/products/industries.
About the Role: We are looking for aClinical Study Manager to join our team, who will be designing, planning, implementing, and managing the overallconduct, or particular elements, of clinical research projects.
You will also ensure compliance with the protocol andoverall clinical objectives as well as applicable standard operating procedures and regulations.This role offers the opportunity to work from a home office in Germany, Spain or Netherlands.
- Coordinating the activities ofinterdisciplinary Gore team members in the planning, executing and closing ofclinical studies
- Developingand approving study-specific documents, tools, presentations and processes
- Delivering study related training
- Preparingand presenting at Investigator meetings
- Participatingin the site qualification, study initiation and study closure process
- Assistingwith the management of medical device distribution, receipt, use and return
- Trackingand reporting progress of studies to applicable internal stakeholdersincluding: patient screening, enrollment, data collection, adverse eventdocumentation and reporting
- Developing StudyReports and providing clinical portions forRegulatory submissions
- Overseeingactivities of site monitors, including reviewing and approving visit reports
- Maintainingfamiliarity with all applicable regulatory requirements and relevant clinicalliterature
- Bachelor’sdegree in science/health related field or nursing degree
- At least 3years of experience in performing clinical studies
- Computerliteracy (e.g. Outlook, Word, Excel, PowerPoint)
- Organizational skills,flexibility, and ability to multi-task
- Experience working on cross-functional teams
- Fluent inEnglish, any other European language is a plus
- Up to 25% of travel required
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