Clinical Study Manager (f/m/d) [HBQ111]

Clinical Study Manager (f/m/d) [HBQ111]

26 mar
W. L. Gore & Associates

26 mar

W. L. Gore & Associates


About Us

: Gore is a materials science company focused on improving lives through discovery, product innovation and rewarding careers for our Associates. About the Industry: Saving lives and improving the quality of life for patients is at the core of everything we do. This meaningful work gives purpose to our lives and inspires us to create solutions that make a difference in the lives of others. Learn more at About the Role:  We are looking for a Clinical Study Manager (f/m/d) to join our EMEA team in Spain or the Netherlands who will design, plan, implement, and manage the overall conduct, or particular elements,

of clinical research projects. In this role you will ensure compliance with the protocol and overall clinical objectives as well as applicable Standard Operating Procedures and regulations. This is a home office opportunity in Spain or the Netherlands. Responsibilities:

- Coordinating the activities of interdisciplinary Gore team members in the planning, executing and closing of clinical studies

- Developing and approving study-specific documents, tools, presentations and processes

- Delivering study related training

- Preparing and presenting at Investigator meetings

- Participating in the site qualification, study initiation and study closure process

- Assisting with the management of medical device distribution, receipt, use and return

- Tracking and reporting progress of studies to applicable internal stakeholders including: patient screening, enrollment, data collection, adverse event documentation and reporting

- Developing Study Reports and providing clinical portions for Regulatory submissions

- Overseeing activities of site monitors, including reviewing and approving visit reports

- Maintaining familiarity with all applicable regulatory requirements and relevant clinical literature

Required Qualifications:

- Bachelor’s degree in science/health related field or nursing degree

- At least 3 years of experience in performing clinical studies

- Computer literacy (e.g. Outlook, Word, Excel, PowerPoint)

- Organizational skills, flexibility, and ability to multi-task

- Fluent in English and Spanish or Dutch, any other European language is a plus

- Experience working on cross-functional teams

- Up to 25% travel might be required

To help us fill this position we are collaborating with our external recruitment agency Elemed. This means your application will be shared with them, and they might then respond to you directly.

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