Gore is a technology-driven global company built on entrepreneurial innovation, integrity, and teamwork. Through our product leadership, we've been changing lives and changing industries including medical devices, fabrics, electronics, and manufacturing for more than 50 years.
The Aortic Business Unit of W. L. Gore & Associates is looking for a clinical study manager to design, plan, implement and manage parts of and/or the overall conduct of clinical research projects. Primary responsibility is to coordinate activities of appropriate Gore Associates, Clinical Site personnel (Investigators, Coordinators, etc.) and external personnel (e.g. CRO) to ensure compliance with the protocol and overall clinical objectives. Emphasis is on travel to Clinical Sites for training. Key responsibilities include:
Additional responsibilities may include:
- Clinical Site training (organizing, documenting & delivering training on regular basis)
- Regular meetings with Clinical Site staff (Investigators, Coordinators, and Monitors)
- Drive site initiation visits to deliver study specific training
- Communicate regularly with Study Team regarding study-related findings
- Development, approval, and distribution of study-related documents and other study tools to Clinical Sites, review committees
- Manage distribution, collection and tracking of regulatory documentation for Clinical Site personnel to ensure compliance at both the Clinical Sites and the Sponsor Central File
- Participate in the Clinical Site qualification and study closure process
- Assist with the management of medical device distribution, receipt, use and return in accordance with applicable regulatory requirements
- Review Case Report Forms (CRFs) for clinical content
- Review Adverse Events for safety and effectiveness information
- Evaluate and analyze clinical data
- Track and report progress of studies including patient screening, enrollment, data collection, adverse event documentation and reporting, and clinical portions of regulatory submissions
- Assist in query writing and resolution process, as required. Identify and gather missing or incomplete data from the investigational sites
- Act as a company liaison to work with Clinical Site
Contract Research Organizations (CROs) and other vendors to resolve any site-related issues
Bachelor's degree in science/health related field
Minimum 2 years experience in clinical/scientific research, nursing, or medical devices/pharmaceutical industry.
Successful experience working on cross-functional teams
Basic computer literacy (e.g., Windows, Word, Excel, PowerPoint, Lotus Notes)
Strong organizational skills, flexibility, and ability to multi-task
Strong verbal and written communication skills
Endovascular medical device experience
Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening.
EEO/AA Employer (applies to all positions located in the U.S.)
North America-United States-Arizona-Phoenix
Yes, 50% of the time
Day (1st shift)
W. L. Gore & Associates - 2 years ago
W. L. Gore & Associates (Gore) is a technology-driven global company built on entrepreneurial innovation, integrity, and teamwork....