About the Role

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.

Responsibilities

• Coordinate the activities of interdisciplinary Gore team members in the planning, executing and closing of clinical studies
• Develop and approve study-specific documents, tools, presentations and 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
• Assist with the management of medical device distribution, receipt, use and return
• Routinely review data / CRFs to ensure data integrity, accuracy and protocol compliance
• 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
• Manage non-compliance for resolution and prevention
• Participate in process improvement efforts
• Maintain knowledge of industry and regulatory trends as required to meet business needs and perform the responsibilities of the position

Required Qualifications

• Bachelor’s degree in a science or health-related field OR a minimum of 5 years 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)

Desired Qualifications

• Experience in clinical research, scientific research, nursing, medical device industry or pharmaceutical 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.