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.
