Clinical Operations Manager

This position is on-site in Seattle, WA. Join Lumen Bioscience as a Clinical Operations Manager to oversee and coordinate clinical operations activities within our growing biopharmaceutical company. In this role you’ll collaborate with cross‑functional teams, manage CROs and clinical research sites, and ensure the successful execution of clinical trials, adherence to regulatory guidelines, and timely delivery of high‑quality clinical data. Duties & Responsibilities Clinical Trial Oversight Plan, implement, and execute clinical trials with cross‑functional teams. Ensure compliance with study protocols, GCP, and regulatory requirements. Monitor trial progress, identify issues, and develop corrective actions. Relationship Management Collaborate with CROs and sites for efficient study start‑up, enrollment, and conduct. Build and maintain effective communication with investigators, site personnel, and vendors. Serve as main point of contact for trial inquiries and issue resolution. Clinical Sample Management Oversee the sample life cycle to maintain chain of custody in a GxP compliant setting. Plan and execute sample processing, tracking, and shipment. Supervise sample receiving procedures and testing timelines. Clinical Trial Supply Management Forecast and manage inventory of investigational product. Establish packaging, labeling, and distribution timelines. Manage third‑party vendor relationships and oversee domestic/international shipments. Documentation and Data Management Collect, process, and archive clinical trial data and documents with accuracy and traceability. Collaborate with the data management team to implement efficient capture and reporting processes. Ensure compliance with data protection regulations. Process Improvement Identify opportunities to streamline operations, enhance efficiency, and optimize resources. Contribute to SOP development and implementation of best practices. Stay current with industry trends and regulatory changes. Qualifications & Requirements Education and Experience Bachelor’s degree in life sciences or related field (advanced degree preferred). Minimum 8 years of clinical operations experience with proven trial management track record. Strong knowledge of GCP, FDA regulations, and related frameworks. Proven leadership with excellent organizational and interpersonal skills. Skills and Attributes Proficiency in CTMS, EDC, and other clinical trial software. Excellent written and verbal communication skills. Detail oriented with strong problem‑solving and decision‑making abilities. Ability to work in a fast‑paced dynamic environment and manage multiple priorities. Adaptability and drive for process improvement. Physical Requirements Operate on-site in Seattle, WA. Sit for extended periods of time (≥ 2 hours). Benefits at Lumen Bioscience Stock bonus Health, dental, and vision premiums fully covered. 401(k) match up to 4%. Industry‑leading PTO, paid refresh days, and paid year‑end holiday office closure. Monthly wellness program. Free on‑site parking or public transportation subsidies. Comprehensive parental leave policies. Life insurance, short & long‑term disability, and employee assistance programs. Compensation Range $110,000 – $120,000 USD As set forth in Lumen Bioscience’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law. #J-18808-Ljbffr