Backed by NEA.
About the role
Execute Clinical Compliance: Implement and maintain the tactical workflows of the clinical QMS, ensuring measurable compliance across all internal software/hardware systems, pharmaceutical CRO clinical operations, and proprietary medical device sponsored studies.
What they're looking for
- University/college degree (life science preferred) in a scientific or technical discipline from an appropriately accredited institution
- A minimum of 6–8+ years of relevant clinical research experience in a combination of research site, biotech/pharma, or CRO environments
- Direct experience with drug and/or medical device clinical trials or clinical data
- Strong, practical working knowledge of ICH Guidelines and GCP, including international regulatory requirements for the conduct of clinical development programs
- Demonstrated ability to manage multiple competing priorities and utilize resources effectively
- Demonstrated ability to build rapport with team members, cross-functional partners, and external clients
More about this role
Passionate about precision medicine and advancing the healthcare industry?
Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
As the Senior Manager of Quality Assurance (QA), you will report directly to the Director of QA and serve as the operational engine driving the execution, management, and continuous improvement of Tempus’ clinical Quality Management System (QMS). Operating at the intersection of cutting-edge AI and clinical compliance, you will manage day-to-day operations to ensure our systems comply with ICH-GCP and applicable international regulations. This vital role supports quality workflows across both our CRO business for pharmaceutical clients and Tempus’s own sponsored medical device clinical trials.
Execute Clinical Compliance: Implement and maintain the tactical workflows of the clinical QMS, ensuring measurable compliance across all internal...
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