(Senior) Clinical Study Manager, Clinical Development
Tempus AI•Chicago, IL
•$110,000 - $160,000
About The Position
Tempus is seeking a highly motivated and detail-oriented Senior Clinical Study Manager (CSM) to join their Clinical Development team. This role 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. The CSM 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.
- 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.
Benefits
- Incentive compensation
- Restricted stock units
- Medical and other benefits depending on the position
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What This Job Offers
Job Type
Full-time
Career Level
Senior
