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This position is on-site in Seattle, WA.
Join Lumen Bioscience as a Clinical Operations Manager to play a vital role in overseeing and coordinating the clinical operations activities within our growing biopharmaceutical company. In this role, you’ll collaborate with cross-functional teams, and manage CROs and clinical research sites, while ensuring the successful execution of clinical trials, adherence to regulatory guidelines, and the timely delivery of high-quality clinical data.
This position combines hands-on leadership of clinical operations activities with clinical trial oversight, relationship management, clinical sample management, clinical trial supply management, documentation and data management, and process improvement. You’ll oversee the planning, implementation, and execution of clinical trials in collaboration with cross-functional teams, collaborate with CROs and clinical trial sites, and oversee and supervise clinical trial sample management life cycle to maintain chain-of custody in a GxP compliant setting. You’ll assist with forecasting and managing inventory of investigational product, manage relationships with third-party vendors, oversee investigational product shipments domestically and internationally, and oversee the collection, processing, and archival of clinical trial data and documents while identifying opportunities to streamline clinical operations processes, enhance efficiency, and optimize resource allocation. If you have strong leadership skills, in-depth knowledge of clinical research processes, and thrive in a fast-paced environment, we encourage you to apply.
Duties & Responsibilities:
Qualifications & Requirements:
Physical Requirements:
Benefits at Lumen Bioscience:
At Lumen Bioscience, we foster a workplace built on collaboration, innovation, and professional growth. This role offers a significant opportunity to contribute directly to cutting-edge biotechnology and the advancement of global health solutions.
Join us to shape innovative solutions and drive operational excellence.
Ready to apply?
Apply to Lumen BioscienceShare this job
This position is on-site in Seattle, WA.
Join Lumen Bioscience as a Senior Clinical Operations Manager to plan, execute and continuously improve clinical operations across multiple clinical studies. In this strategic, cross-functional role, you’ll lead operational strategy and execution for one or more clinical development programs, oversee CRO and vendor selection and performance, manage study budgets and timelines, ensure regulatory readiness and inspection response, and support the career development of the operations team while being accountable for delivering high-quality data on time and on budget.
This position combines program ownership and strategy, team leadership, CRO and vendor management, budget and resource ownership, quality and compliance, clinical trial execution, data and documentation, process improvement and SOPs, and cross-functional leadership. You’ll create program timelines, resourcing plans, and run-rate forecasts; manage vendor KPIs and SLAs and drive performance improvements; own program budgets and control spend; ensure inspection readiness and lead remediation after audits; oversee site selection and activation, enrollment performance, monitoring strategy, and vendor deliverables; ensure eTMF completeness and adherence to GCP/ICH and applicable regulations; and drive continuous improvement and implementation of SOPs and automation to increase efficiency and quality while presenting program status to leadership and the executive team.
If you bring deep clinical operations experience, strong leadership, communication, negotiation and problem-solving skills, and a passion for advancing clinical development programs, we encourage you to apply.
Duties & Responsibilities:
Qualifications & Requirements:
Physical Requirements:
Benefits at Lumen Bioscience:
At Lumen Bioscience, we foster a workplace built on collaboration, innovation, and professional growth. This role offers a significant opportunity to contribute directly to cutting-edge biotechnology and the advancement of global health solutions.
Join us to shape innovative solutions and drive operational excellence.
Ready to apply?
Apply to Lumen BioscienceCookies & analytics
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