(Senior) Clinical Study Manager, Clinical Development

Tempus AI•Chicago, IL

About The Position

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.

Requirements

Bachelor’s degree in a 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.
Proficiency with EDC systems, CTMS, and eTMF platforms.
Exceptional project management, communication, and problem-solving skills.
Ability to work in a fast-paced, "startup" environment.

Nice To Haves

Advanced degree such as MS, MPH, or PhD preferred.
Experience with Real-World Data (RWD) or retrospective cohort studies is highly desirable.
Familiarity with SQL or data visualization tools is a plus.

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 Standard Operating Procedures (SOPs).
Work closely with Medical Affairs, Product, Legal, and Engineering teams to align study objectives with company milestones.
Manage study milestones, identify potential risks to timelines, and implement mitigation strategies to keep projects on track.