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Clinical Study Manager
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Gore is a technology-driven global company built on entrepreneurial innovation, integrity, and teamwork. Our diverse portfolio includes everything from high-performance fabrics and implantable medical devices to industrial manufacturing components and aerospace electronics. Through our product leadership, we've been changing lives and changing industries for more than 50 years. What can you change by joining Gore? Visit gore.com/change-life to find out.
Gore Medical Products has provided creative therapeutic solutions to complex medical problems for 40 years. During that time, 40 million innovative Gore Medical Devices have been implanted, saving and improving the quality of lives worldwide. Our extensive family of products includes vascular grafts, endovascular and interventional devices, surgical meshes for hernia and soft tissue reconstruction, staple line reinforcement materials, and sutures for use in vascular, cardiac, and general surgery. We are looking for a Clinical Study Manager to join our rapidly growing business. This role can be based remote from home or in one of our facilities in Flagstaff or Phoenix, AZ.
The role of the Clinical Study Manager (CSM) is focused on designing, planning, implementing, and managing the overall conduct, or particular elements, of clinical research projects. The goal of the CSM is to ensure compliance with the protocol and overall clinical objectives as well as applicable SOPS and regulations.
The ideal candidate will:
* Be passionate about managing clinical studies for state-of-the art implantable medical devices
* Be energized by working for a world-class manufacturer and collaborating on cross-functional teams
* Recognize the importance of building and maintaining strong interpersonal relationships
* 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
* Selecting and coordinating DSMB/CEC/Steering Committees, when applicable
* 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
* Routinely reviewing data/CRFs to ensure data integrity, accuracy and protocol compliance
* 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 reports for Regulatory submissions
* Assisting in query writing and resolution process
* Identifying and gathering missing or incomplete data from investigational sites
* Conducting site visits, as necessary
* Acting as a company liaison to work with clinical sites, Contract Research Organizations (CROs) and other vendors
* Overseeing activities of site monitors, including reviewing and approving visit reports
* Managing non-compliance for resolution and prevention
* Budget forecasting and payment approvals
* Maintaining familiarity with all applicable regulatory requirements and relevant clinical literature
REQUIRED JOB QUALIFICATIONS
* Bachelors degree in a science/health related field and at least two years of experience in clinical research OR at least 5 years of clinical research in the medical device or pharmaceutical industry
* Ability to positively influence associates, both internally and externally
* Strong organizational skills, flexibility, and ability to multi-task
* Strong verbal and written communication skills
* Experience working on cross-functional teams
* Ability to work on a remote team
* Travel as necessary to achieve business and project objectives (~25%)
DESIRED JOB QUALIFICATIONS
* 4 years of experience in clinical research in the medical device or pharmaceutical industry
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Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening.
Gore requires all applicants to be eligible to work within the US. Gore generally will not sponsor visas unless otherwise noted on the position description.
Gore is a M/F, Disabled and Vet EEO/AA Employer. (Applies to all positions in the U.S.)