Job description
About Us: Gore is a materials science company focused on improving lives through discovery, product innovation and rewarding careers for our Associates.
About the Industry: Saving lives and improving the quality of life for patients is at the core of everything we do. This meaningful work gives purpose to our lives and inspires us to create solutions that make a difference in the lives of others. Learn more at gore.com/products/industries
About the Role: We are looking for a Clinical Study Manager (CSM) to join our team and focus 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 developing clinical trial plans
- Experience working with EDC, CTMS, or eTMF systems
- 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
- Remote Working Arrangements are permitted for Associates in the continental United States (US) and Canada, with appropriate approval and compliance with Gore’s remote working policies, from the country in which they are employed. Locations not eligible for new remote work arrangements include: Alaska and Hawaii (for all roles), and Rhode Island (for wage/hourly roles only).
What We Offer: At Gore, we offer comprehensive, competitive rewards in the form of compensation and benefits. Among these are work-life balance and sports programs, 401(k) Plan with a gift, Associate Stock Ownership Plan, health & well-being program with full health plan, and a flexible working program. Within Gore, you will find a unique culture, diversity, equity, and inclusion initiatives, and opportunities for growth and development. Learn more at gore.com/careers
We believe in the strength of a diverse workforce and inclusive work environment. In support of our values and continued success we are proud of Associates around the world who support an inclusive work environment, strive to reflect the diversity of the communities where we operate, and ensure all Associates and external partners are treated with fairness, dignity and respect.
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