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Job Summary |
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Clinical Operations Professional
Job Code: 01155
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POSTED: Nov 05
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| Salary: |
Open |
Location: |
Flagstaff, AZ |
| Employer: |
W.L. Gore & Associates, Inc. |
Type: |
Full Time - Experienced |
| Category: |
Quality |
Required Education: |
4 Year Degree
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Job Description |
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Partner with the Clinical Affairs Teams to drive operational excellence throughout the clinical research processes. Develop, implement, and continuously improve processes to increase the efficiency and effectiveness of the Clinical Affairs organization. Key responsibilities include: · Apply proven process mapping and project management methodologies to the development and improvement of clinical processes · Drive regulatory compliance through the development and implementation of processes consistent with FDA regulations and Good Clinical Practices · Research best clinical practices and perform benchmarking against the research industry · Ensure the scalability of processes, tools, and systems to meet Clinical Affairs' future growth needs · Assemble and lead core teams to participate in requirement definition, development, and implementation of new processes · Implement process changes that produce measurable improvements in efficiency and quality · Develop user-friendly tools and systems to facilitate the performance of clinical studies and assure quality · Writing SOPs, guidelines and work instructions · Develop (or co-develop) and deliver process-related training · Manage the change process for minimum disruption and maximum efficiency · Continually evaluate, update, and improve clinical processes through a periodic review process · Develop new processes and process changes related to the adoption of new technologies · Interface with the Quality organization to ensure compliance with Medical Product Division quality standards · Work with Divisional and Enterprise Operational Excellence teams to drive process change and technology initiatives
| NOTES: |
Additional Salary Information: Commensurate with experience
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Requirements |
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3+ years experience in project management and/or operations 3+ years clinical research experience in medical device, pharmaceutical or biotech industry Bachelor's degree Solid business process improvement experience Successful experience working on cross-functional teams Proven organizational skills, flexibility, and ability to multi-task Basic computer literacy (e.g., Windows, Word, Excel, PowerPoint, Lotus Notes) and MS Access and MS Project (or similar project management applications) Strong verbal and written communication skills, including technical writing skills Must pass background screen Desired Working knowledge of FDA regulations and Good Clinical Practices Experience with Lean, Six Sigma or related methodologies
All interested applicants must apply online at www.gore.com/careers to be considered for this position.
EEO/AA Employer
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