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Work Background
VarianSenior Clinical Operations Manager
Dec. 2021 - Mar. 2023Seattle, Washington, United States• Wrote, refined, and followed departmental SOPs and Work Instructions.
• Managed project schedules through scope changes and competing priorities.
• Planned, facilitated, and documented staff and clinical study training.
• Reviewed external-facing communications for compliance with regulations.
• Developed a project management system for publication projects.
• Interviewed and provided feedback on job candidates.
• Collaborated with stakeholders in multiple departments
• Supervised employees and contractors.
• Edited press releases.
• Wrote up and published research results.
• Created graphs, graphics, slides, and flyers.
• Developed, delivered, and evaluated training programs.
• Managed departmental Sharepoint site. • Monitored research records at clinical study sites.
• Created electronic versions of paper case report forms (CRFs).
• Modified CRFs to improve thorough and accurate data collection.
• Issued and ensured resolution of electronic database (EDC) queries.
• Published technical research in journals and conferences. • Served as a reviewer for high-impact journals.
• Analyzed and described data.
• Visited, reviewed, and selected sites for clinical trials.
• Developed site initiation visit (SIV) slides on protocols, SOPs, regulations, and good clinical practice (GCP).
• Developed instructions for developing project-specific Monitoring Plans.
• Designed, monitored, and reported on clinical trials.
• Reviewed study proposals, modified protocols, and supported PI-initiated clinical studies.
• Partnered with sites’ clinical research coordinators to initiate and run clinical trials.
• Collaborated with and provided clinical evaluation reports (CERs) to colleagues in Europe and Asia for CE Mark and China FDA applications.
• Participated in in-person 510(k) meetings at the FDA.
• Managed collaborative relationships with a diverse set of Principal Investigators.
• Created deliverables for internal and external customers
Varian Medical SystemsClinical and Collaborations Project Manager II
Mar. 2013 - Aug. 2016Greater Seattle AreaLearned the details of federal regulations specific to the project, and secured compliance from our contractors. Designed and created graphics, slides, and flyers for the Vice President of Medical Affairs.
Managed project tasks and timelines for the department.
Coordinated full-day training sessions for teams across multiple organizations.
Cross-checked records, and secured corrections.
Wrote reports for project managers across the corporation, including colleagues based in China, Germany, and England. Arranged resources to complete all reports on schedule. - Coordinated and conducted staff onboarding and completion of required training; - Coordinated the logistics for full-day training sessions, including managing schedules of teams from multiple departments, obtaining meeting spaces, and acquiring specialized equipment. - Developed content and traveled independently around the United States to deliver educational programs for diverse teams of professional and non-professional researchers. - Led hands-on, informal one-on-one, and classroom-based training sessions. - Designed graphics, slides, worksheets, and flyers for presentation and distribution. - Created and conducted onboarding and ongoing training for the Clinical Research Assistants under my management. Leadership: - Managed Clinical Research Associates. - Tracked project tasks and timelines for the department and flagged upcoming conflicts for review.
Varian Medical SystemsClinical and Collaborations Project Manager I
Jun. 2012 - Mar. 2013Greater Seattle Area
University of Maryland School of MedicineResearch Assistant
Jun. 2008 - Jun. 2012Baltimore, Maryland Area
Innoventor, Inc.Project Engineer
Oct. 2007 - Mar. 2008Earth City, MO
Washington University School of MedicineResearch Assistant
Jan. 2006 - Dec. 2007Greater St. Louis Area
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