Clinical Study Manager - Remote

We are looking for a Clinical Study Manager (CSM) to join our team from a remote home office within the United States. In this role, the 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.

This is a remote position, and you can work from home in most locations within the United States.

• Coordinatethe activities of interdisciplinary Gore team members in the planning, executingand closing of clinical studies
• Developand approvestudy-specific documents, tools, presentationsand processes
• Overall oversight of clinical studies including activities of site monitors, clinical vendors, review and approval of site visit reports, selection and coordination of DSMB / CEC / Steering Committees, and participation in site visits as necessary
• Assistwith the management of medical device distribution, receipt, useand return
• Routinely reviewdata / CRFs to ensure data integrity, accuracyand protocol compliance
• Trackand reportprogress of studies to applicable internal stakeholders, including patient screening, enrollment, data collection, adverse event documentationand reporting
• DevelopStudy Reports and provideclinical portions for Regulatory submissions
• Managenon-compliance for resolution and prevention
• Participatein process improvement efforts
• Maintainknowledge of industry and regulatory trends as required to meet business needs and performthe responsibilities of the position

• Bachelor's degree in a science orhealth-related field ORa minimum of 5years clinical research experience
• Experience working on cross-functional teams
• Basic computer literacy (e.g., Windows, Word, Excel, PowerPoint)
• Organizational skills, flexibility, and ability to multi-task
• Strong verbal and written communication skills
• Ability to travel up to 30%, including international travel (Travel is primarily U.S. based)

• Experience in clinical research, scientific research, nursing, medical device industryorpharmaceutical industry

This position offers a remote work arrangement in the country from which the Associate is employed. Eligibility is dependent on the responsibilities of the role and business needs, and the Associate must agree to comply with Gore's work arrangement policies.

Note: In the United States, restrictions exist for remote work from Alaska, Hawaii and Rhode Island.