Clark Winchell
Senior Director, Clinical Quality Assurance @Ora
Signup · Get unlimited contacts
WORK HISTORY
Senior Director, Clinical Quality Assurance @Ora
Andover, MA, US
Manage a team of 8; provide full quality oversight and support to the organization; report directly to Chief Executive Officer (CEO) Develop, maintain, and continuously improve Ora’s Quality Management System (QMS) Serve as the quality assurance Subject Matter Expert within Good Clinical Practice (GCP) Act as the quality assurance liaison with internal and external cross-functional teams and clients Develop and maintain quality assurance related metrics for the company’s CEO & Executive Team Regularly review and revise the company’s Standard Operating Procedures (SOPs) and other controlled documents Investigate and report on quality assurance related issues including root cause analysis and corrective action and preventive action (CAPA)
EDUCATION
Bates College
Bachelor of Science, Biology
Bates College
Bachelors of Science, Biology
SKILLS
ABOUT CLARK WINCHELL
MANAGEMENT PROFESSIONAL – HEALTHCARE / CLINICAL RESEARCH EDUCATION/COMPLIANCEProgressive and dedicated career applying a key blend of knowledge and skills in clinical oversight, research processes and practices, and employee training in a challenging healthcare research environment. Recognized for strong work ethic in intensive and time-sensitive projects. Very strong people skills, with a focus on team building, ensuring quality and clinical compliance. Skilled in study planning, SOP writing, gap analysis, root cause analysis. B.S, Biology. Certifications: CITI, NIH, CPR. Technical Skills: Microsoft Office (Word, Excel, PowerPoint), IXRS, imednet, MediaLab.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.