Senior Clinical Study Manager - Remote

W.L. Gore & Associates • Flagstaff, AZ

256d • Remote

About The Position

We are looking for an experienced Clinical Study Manager (CSM) to join the Clinical Affairs Team, and ensure compliance with the protocol, overall clinical objectives, and applicable SOPs and regulations. This will be accomplished through planning, implementing, and managing the overall conduct or particular elements of clinical research projects. This is a remote position, and you can work from home in most locations within the United States.

Requirements

• Bachelor's degree in a science or health-related field
• Minimum of 3 years Sponsor experience in clinical research
• Experience developing clinical trial plans including: protocol development, site monitoring, risk mitigation strategies, trial budgets and site selection/feasibility
• Experience leading and working on cross-functional teams
• Basic computer literacy (e.g., Windows, Word, Excel, PowerPoint, EDC, CTMS, eTMF)
• Strong organizational skills, flexibility, and ability to multi-task
• Effective verbal and written communication skills
• Ability to travel up to 30%

Nice To Haves

• Experience in clinical research, scientific research, nursing, medical device industry or pharmaceutical industry
• Minimum of 3 years Project Management experience

Responsibilities

• Lead the activities of interdisciplinary Gore team members: plan, execute, and close complex global clinical studies
• Provide study leadership within the project team to foster inclusive teamwork, cooperation and to provide strategic direction on operational study needs
• Responsible to ensure clinical study meets timelines, quality standards and projected cost estimates
• Develop and approve study-specific documents, tools, presentations, and processes
• Oversight of clinical studies to include 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
• Track and report progress of studies to applicable internal stakeholders, to include patient screening, enrollment, data collection, protocol compliance, device accountability, 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

Benefits

• Comprehensive and competitive total rewards program
• Choice and flexibility in benefits promoting overall well-being
• Distinctive Associate Stock Ownership Plan
• Potential opportunities for profit-sharing

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree