Clinical Trial Lead
Posted on 7/26/2022
INACTIVE
AI-driven precision medicine through clinical and molecular data analysis
Company Overview
Tempus Labs, Inc. is a leader in precision medicine, leveraging artificial intelligence to analyze vast clinical and molecular data, enabling physicians to deliver personalized, data-driven care. The company's advanced machine learning platform and unique solution sets facilitate the discovery, development, and delivery of optimized therapeutic options for patients. With a focus on extensive molecular profiling, Tempus has developed a robust pan-cancer tumor organoid platform and validated a liquid biopsy assay, demonstrating their commitment to transforming personalized patient care and their position at the forefront of the healthcare industry.
AI & Machine Learning
Data & Analytics
Company Stage
Series G
Total Funding
$1.3B
Founded
2015
Headquarters
Chicago, Illinois
Growth & Insights
Headcount
6 month growth
↑ 6%1 year growth
↑ 26%2 year growth
↑ 49%Locations
San Francisco, CA, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Requirements
- Minimum of five (5) years relevant clinical research experience in a combination of research site, biotech or pharma, or CRO experience
- Minimum of one (1) year experience as a Clinical Trial Lead or equivalent (Clinical Trial/Study Manager) or relevant clinical operations experience at a CRO, biotech or pharma company
- Or equivalent demonstrated skill set
- Plus: In-depth knowledge of clinical trials; the ability to see the bigger picture and prioritize the critical elements of success
Responsibilities
- Manage clinical operations deliverables including timeline, quality, scope, and financials
- Works closely with the Project Manager to develop plans, monitor resource allocation and ensure that clinical site management and monitoring is being delivered per contract with quality and efficiency
- Proactively identify risks and escalate to Project Manager and other appropriate functional leads
- Together with the Project Manager, ensure transparent communication both internally and externally regarding study progress and issues
- Anticipate client needs and proactively resolve issues as necessary
- Develop and maintain project-specific clinical operations plans as required per project (e.g. Clinical Monitoring Plan, Cohort Management Plan, Recruitment Plan, etc.)
- Develop and maintain project-specific clinical operations reference materials and tools, including study-specific forms and logs
- Develop training materials and conduct training for the clinical operations team throughout the project lifecycle
- Provide operational oversight for site and CRA deliverables and key performance indicators such as site activation, subject recruitment, site monitoring visits, data currency and quality
- Manage CRA resourcing, site assignments, visit schedules and serve as the initial point of contact for clinical operations and monitoring issues
- Review and approve site monitoring visit reports; monitor and track related metrics for compliance with Clinical Monitoring Plan and Highline SOPs
- Conduct monitoring visits, co-monitoring visits, assessment visits and/or team training as necessary
Desired Qualifications
- Prior experience in a Clinical Research Associate related role at a CRO, biotech or pharma company
- Early phase clinical trial experience