(Senior) Clinical Study Manager, Clinical Development

Tempus AI; Chicago (IL); On-site; USD 110,000 - 160,000; Full time

Job summary

Tempus AI is seeking a Senior Clinical Study Manager to lead prospective and retrospective clinical studies within our Clinical Development team. You will oversee study design, vendor relationships, data integrity, and regulatory compliance to deliver high-quality Real-World Evidence that informs oncology care.

Ideal candidates will have 5+ years of trial management in Biotech/Pharma/CRO, strong project management, and experience with EDC/CTMS/eTMF.

Qualifications

• Bachelor's degree in Life Sciences, Nursing, or related field; advanced degree preferred.
• 5+ years of clinical trial management experience in Biotech, Pharma, or CRO environment.
• Strong understanding of oncology and/or molecular diagnostics; experience with RWD or retrospective cohorts is desirable.
• Proficiency with EDC, CTMS, and eTMF platforms; SQL or data visualization familiarity is a plus.
• Excellent project management, communication, and problem-solving skills; able to thrive in a startup-like environment.

Responsibilities

• Lead end-to-end management of multiple clinical studies, including prospective observational trials and retrospective RWE studies.
• Develop study protocols, ICFS, CRFs, and study-specific manuals.
• Oversee CROs, central labs, and clinical trial sites; identify sites and assess feasibility.
• Partner with Data Science and Bioinformatics teams to ensure high-quality data collection and clean datasets for retrospective analysis.
• Ensure compliance with ICH-GCP, HIPAA, and SOPs; maintain regulatory readiness.
• Collaborate with Medical Affairs, Product, Legal, and Engineering to align study objectives with company milestones.
• Track timelines and budgets; identify risks and implement mitigation strategies to keep projects on track.

Skills

Project management

Communication

Problem solving

Data integrity

Vendor management

Site management

Budget & timeline tracking

Oncology knowledge

RWD awareness

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences or related field

Advanced degree (MS/MPH/PhD) preferred

Tools

EDC systems

CTMS

eTMF platforms

SQL

Data visualization tools

Job description

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.