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:
- Clinical Trial Oversight:
- Oversee the planning, implementation, and execution of clinical trials in collaboration with cross-functional teams, including regulatory affairs, medical writing, production and development, and data management.
- Ensure compliance with study protocols, Good Clinical Practice (GCP) guidelines, and relevant regulatory requirements.
- Monitor clinical trial progress, identify potential issues, and proactively develop and implement corrective actions.
- Relationship Management:
- Collaborate with Contract Research Organizations (CROs) and clinical trial sites to ensure efficient study start-up, enrollment, and conduct.
- Facilitate effective communication and build strong relationships with external partners, including investigators, site personnel, and vendors.
- Serve as the main point of contact for clinical trial-related inquiries and issue resolution.
- Clinical Sample Management:
- Oversee and supervise clinical trial sample management life cycle to maintain chain-of custody in a GxP compliant setting
- Work closely with CRO, external lab vendors and internal teams to plan and execute sample processing, tracking and shipment of clinical samples
- Oversee sample receiving procedures and sample testing timelines
- Clinical Trial Supply Management:
- Assist with forecasting and managing inventory of investigational product needed for upcoming and ongoing clinical trials
- Establish packaging, labeling and distribution timelines
- Manage relationships with third-party vendors, e.g., shipping companies and IRT providers.
- Oversee investigational product shipments domestically and internationally, including coordination of import/export documentation, permits and licenses to ensure timely and compliant delivery of investigational product to drug depots and clinical research sites.
- Documentation and Data Management:
- Oversee the collection, processing, and archival of clinical trial data and documents, ensuring accuracy, completeness, and traceability.
- Collaborate with the data management team to implement efficient data capture and reporting processes.
- Ensure compliance with data protection regulations and maintain data confidentiality.
- Process Improvement:
- Identify opportunities to streamline clinical operations processes, enhance efficiency, and optimize resource allocation.
- Contribute to the development and implementation of standardized operating procedures (SOPs) and best practices.
- Stay up to date with industry trends and regulatory changes to ensure the adoption of current best practices.
Qualifications & Requirements:
- Education and Experience:
- Bachelor's degree in life sciences or a related field (advanced degree preferred).
- Minimum of 8 years of experience in clinical operations, with a demonstrated track record of managing clinical trials.
- Strong knowledge of GCP guidelines, FDA regulations, and other relevant regulatory frameworks.
- Proven experience in leading and managing teams, with excellent organizational and interpersonal skills.
- Skills and Attributes:
- Proficiency in clinical trial management systems (CTMS), electronic data capture (EDC) systems, and other relevant software applications.
- Excellent written and verbal communication skills, with the ability to effectively communicate complex information to diverse stakeholders.
- Detail-oriented, with strong problem-solving and decision-making abilities.
- Ability to work effectively in a fast-paced, dynamic environment and manage multiple priorities simultaneously.
- Demonstrated ability to adapt to changing circumstances and proactively drive process improvements.
Physical Requirements:
- Ability to work on-site in Seattle, WA
- Ability to sit for extended periods of time (2 or more hours)
Benefits at Lumen Bioscience:
- Stock bonus
- Health, Dental, and Vision premiums fully covered by Lumen
- 401k match up to 4%
- Industry-leading PTO policy, paid refresh days, and paid year-end holiday office closure
- Monthly wellness program to support your health and well-being
- Free onsite parking or public transportation subsidies
- Comprehensive parental leave policies
- Life insurance, short & long-term disability, and access to employee assistance programs
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.