Study Manager I
Core
Manage analytical studies and phases in the capacity of a Study Director, Principal Investigator, or Responsible Scientist, ensuring compliance with GLP/GCP and delivering scientific, technical, and regulatory results.
Role type
Senior IC Study Manager (Immunotoxicology/Cell Biology)
Builds
Analytical study protocols, validated assays, and scientific reports for pharmaceutical and health system clients
Domain
Life Sciences / Immunotoxicology / Laboratory Services
Required skills
PhD in cell biology or immunology, flow cytometry analysis, cell-based assay design, multiplex cytokine analysis, ELISA, dd-PCR/digital PCR, GLP/GCP regulatory compliance, protocol development, client liaison, assay troubleshooting, method validation
Preferred skills
FDA/EMA/NMPA regulatory experience, client management, complex technical challenge resolution, mentoring junior staff, new assay development
Technologies
Flow cytometry, ELISA, dd-PCR, digital PCR, multiplex cytokine analysis platforms
Responsibilities
Develop and approve study protocols ensuring SOP and regulatory compliance; Monitor study progress and verify experimental data accuracy; Liaise with clients to manage study changes and timelines; Conduct method validation and standalone studies; Troubleshoot assays and resolve technical issues; Mentor team members and conduct peer reviews
Seniority
Senior, hands-on IC