(Senior) Clinical Study Manager, Clinical Development

Tempus AI, Inc.; North Carolina; On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Incentive compensation

Stock options/RSUs

Medical benefits

Job summary

Tempus AI, Inc. is seeking a Senior Clinical Study Manager to lead and execute complex clinical studies within our Clinical Development team.

You will drive study design, governance, and operational success across prospective and retrospective evidence projects, partnering with oncology, genomics, and data science groups. The role requires 5+ years of trial management experience in biotech, pharma, or CROs, with strong knowledge of ICH-GCP and HIPAA standards.

Qualifications

• Bachelor’s degree in Life Sciences, Nursing, or related field.
• 5+ years of clinical trial management experience within a Biotech, Pharma, or CRO environment.
• Strong understanding of oncology and/or molecular diagnostics. Experience with Real-World Data (RWD) or retrospective cohort studies is highly desirable.
• Proficiency with EDC systems, CTMS, and eTMF platforms. Familiarity with SQL or data visualization tools is a plus.
• Exceptional project management, communication, and problem-solving skills. Ability to work in a fast-paced, startup environment.

Responsibilities

• Lead the end-to-end management of multiple clinical studies, including prospective observational trials and retrospective Real-World Evidence (RWE) studies.
• Develop study protocols, Informed Consent Forms (ICFs), Case Report Forms (CRFs), and study-specific manuals.
• Oversee CROs, central labs, and clinical trial sites. Conduct site identification, feasibility assessments, and maintain strong relationships with Principal Investigators.
• Partner with Data Science and Bio-informatics teams to ensure high-quality data collection and clean datasets for retrospective analysis.
• Ensure all study activities adhere to ICH-GCP guidelines, HIPAA regulations, and internal SOPs.
• Work closely with Medical Affairs, Product, Legal, and Engineering teams to align study objectives with company milestones.
• Manage study milestones, identify risks to timelines, and implement mitigation strategies to keep projects on track.

Skills

Project management

Communication

Problem solving

Startup environment

Education

Bachelor’s degree in Life Sciences, Nursing, or related field

Tools

EDC systems

CTMS

eTMF platforms

SQL

Job description

Overview

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. We are seeking a highly motivated and detail-oriented Senior Clinical Study Manager (CSM) to join our Clinical Development team. In this role, you will lead the planning, execution, and management of both prospective and retrospective clinical evidence generation studies. The ideal candidate thrives at the intersection of oncology, genomics, and data science. You will be responsible for ensuring that clinical studies are conducted with the highest quality standards, on time, and within budget, while leveraging Tempus’s unique multimodal data platform.

Key Responsibilities

• Study Leadership: Lead the end-to-end management of multiple clinical studies, including prospective observational trials and retrospective Real-World Evidence (RWE) studies.


• Operational Planning: Develop study protocols, Informed Consent Forms (ICFs), Case Report Forms (CRFs), and study-specific manuals.


• Vendor & Site Management: Oversee CROs, central labs, and clinical trial sites. Conduct site identification, feasibility assessments, and maintain strong relationships with Principal Investigators.


• Data Integrity: Partner with Data Science and Bio-informatics teams to ensure high-quality data collection and clean datasets for retrospective analysis.


• Compliance: Ensure all study activities adhere to ICH-GCP guidelines, HIPAA regulations, and internal Standard Operating Procedures (SOPs).


• Cross-functional Collaboration: Work closely with Medical Affairs, Product, Legal, and Engineering teams to align study objectives with company milestones.


• Timeline & Budget Tracking: Manage study milestones, identify potential risks to timelines, and implement mitigation strategies to keep projects on track.

Qualifications

• Education: Bachelor’s degree in a Life Sciences, Nursing, or related field (Advanced degree such as MS, MPH, or PhD preferred).


• Experience: 5+ years of clinical trial management experience within a Biotech, Pharma, or CRO environment.


• Domain Expertise: Strong understanding of oncology and/or molecular diagnostics. Experience with Real-World Data (RWD) or retrospective cohort studies is highly desirable.


• Technical Skills: Proficiency with EDC systems, CTMS, and eTMF platforms. Familiarity with SQL or data visualization tools is a plus.


• Soft Skills: Exceptional project management, communication, and problem-solving skills. Ability to work in a fast-paced, "startup" environment.

#LI-NK1 $110,000 - $160,000

The expected salary range above is applicable if the role is performed from Illinois and may vary for other locations (California, Colorado, New York). Actual salary may vary based on qualifications and experience.

Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.

We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Tempus was founded in August of 2015 by Eric Lefkofsky, after his wife was diagnosed with Breast Cancer. Shortly after he founded the company in an effort to bring the power of technology and artificial intelligence to cancer care, he convinced Ryan Fukushima to join as the company’s first employee. Ryan and Eric began assembling a world class team, focused on building the first version of a platform capable of ingesting real time healthcare data in an effort to personalize diagnostics. We built the platform for oncology and have expanded it to neuropsychiatry, cardiology, infectious disease (through COVID), and radiology. Despite our rapid growth, our mission remains the same—to help make sure patients are on the right drug at the right time, so they can live longer and healthier lives. We’re looking for people who can change the world. Who question the status quo and don’t shy away from tough problems. For the builders who are never done building and the learners who are never done learning. We’re looking for passionate people with undying curiosity. Those who want to attack one of the most challenging problems mankind has ever faced. Head on.