Clinical Study Manager jobs in United States
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Tempus AI · 1 day ago

Clinical Study Manager

Tempus AI is a company focused on precision medicine and advancing the healthcare industry through AI technology. They are seeking a Clinical Study Manager to independently plan, execute, monitor, and close observational studies while ensuring compliance with quality standards and effective communication with clients and project teams.

Artificial Intelligence (AI)BiotechnologyHealth CareMachine LearningMedicalPrecision Medicine
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H1B Sponsor Likelynote

Responsibilities

Responsible for executing Tempus’s observational trials in compliance with quality standards (ICH/GCP, Global Regulations, and Tempus policies and procedures)
Act as primary point of contact for clients. Anticipate client needs and proactively resolve issues as necessary
Lead cross-functional teams and third parties/vendors to ensure effective teamwork and communication
Manage project deliverables including timeline, quality, scope, and cost
Maintain study management system(s)
Develop and maintain project plans
Primary contact for assigned sites and build positive relationships with investigators and site staff
Complete monitoring visits and/or oversee Clinical Research Associates, as applicable
Manage participant recruitment, sample reconciliation, data entry to safe-guard project endpoints
Responsible for the completeness and quality of the Trial Master File
Provide temporary coverage/back-up for additional observational studies as required
May involve overnight travel

Qualification

Clinical research experienceICH Guidelines knowledgeGCP knowledgeProject finance knowledgeObservational studies experiencePlanning skillsSelf-directedCommunication skillsOrganizational skills

Required

University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution
Minimum of five+ (5) years relevant clinical research experience in a combination of research site, life sciences company or CRO
Working knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
Demonstrated ability to handle multiple competing priorities and to utilize resources effectively
Demonstrated ability to be self-directed
Working knowledge of project finance
Familiar with concepts commonly incorporated non-therapeutic studies: risk-based monitoring, quality of life and patient-reported outcomes, health outcomes etc
Excellent communication, planning and organizational skills

Preferred

Experience with observational/non-interventional studies, registries, comparative effectiveness studies, etc
Prior experience working for both a sponsor/life science company and a CRO
Previous clinical monitoring experience

Benefits

Incentive compensation
Restricted stock units
Medical and other benefits

Company

Tempus AI

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Tempus is making precision medicine a reality by applying AI in healthcare, deriving insights from our expansive library of clinical data and molecular data.

H1B Sponsorship

Tempus AI has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (3)

Funding

Current Stage
Public Company
Total Funding
$2.29B
Key Investors
Ares ManagementGoogleBaillie Gifford
2025-06-30Post Ipo Debt· $650M
2025-02-19Post Ipo Debt· $300M
2024-06-14IPO

Leadership Team

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Eric Lefkofsky
Founder and CEO
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Shane Colley
CTO
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Company data provided by crunchbase