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Clinical Study Manager Experienced - Remote - Phoenix Arizona
Company: W.L. Gore & Associates Location: Phoenix, Arizona
Posted On: 04/25/2024
About the Role: We are looking for an Experienced Clinical Study Manager (CSM) to join our team. 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
R equired Qualifications: - Bachelor's degree in a science or health-related field OR a minimum 5 years clinical research experience
- Minimum 3 years Sponsor experience in clinical research, scientific research, medical device industry or pharmaceutical industry
- 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
Desired Qualifications: |
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