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