Clinical Study Manager (f/m/d)
W.L. Gore & Associates
About the Role: We are looking for a Clinical Study Manager (f/m/d) to join our EMEA Clinical Team who is focused on designing, planning, implementing, and managing the overall conduct, or particular elements of clinical research projects. The goal of the Clinical Study Manager (f/m/d) is to ensure compliance with the protocol and overall clinical objectives, as well as applicable standard operating procedures and regulations.
This is a temporary role for 18 months and offers the opportunity to work from a remote office.
- Coordinate the activities of interdisciplinary Gore team members in the planning, executing and closing of clinical studiesDevelop and approve study-specific documents, tools, presentations and processes
- Deliver study related training
- Prepare and present at investigator meetings
- Participate in the site qualification, study initiation and study closure process
- Assist with the management of medical device distribution, receipt, use and return
- Track and report progress of studies to applicable internal stakeholders including: patient screening, enrollment, data collection, adverse event documentation and reporting
- Develop study reports and provide clinical portions for regulatory submissions
- Oversee activities of site monitors, including reviewing and approving visit reports
- Maintain familiarity with all applicable regulatory requirements and relevant clinical literature
- Bachelor’s degree in science/health related field or nursing degree
- At least 3 years of experience in performing clinical studies
- Experience working on cross-functional teams
- Organizational skills, flexibility, and ability to multi-task
- Computer literacy (e.g. Outlook, Word, Excel, PowerPoint)
- Fluent in English, any other European language is a plus
- Up to 20% travel might be required
What We Offer: Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow.
We provide benefits that offer choice and flexibility and promote overall well-being. And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for “profit-sharing”. Learn more at gore.com/careers/benefits
We believe in the strength of a diverse and inclusive workplace. With diverse perspectives, ideas and experiences, we uncover new possibilities and make a greater impact in the world. We are proud of Associates for building on our rich history of innovation, upholding our values and supporting an inclusive work environment where we treat each other and our external partners with fairness, dignity and respect.
Gore is an equal opportunity employer. We welcome all applications irrespective of race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a covered veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations.
Our Talent Acquisition Team welcomes your questions at gore.com/careers/contact