Manager, Clinical Research
Core
Oversees development of clinical trials and research programs, executes regulatory strategies, and coordinates study protocols and data collection fidelity.
Role type
Manager, Clinical Research
Builds
Clinical trials and research programs supporting the University's mission
Domain
Academic medical center / Clinical Research / Regulatory Affairs
Deliverable
client delivery
Required skills
Clinical research program management, Regulatory affairs (IND/IDE), SOP development, Team leadership, Budget management, Audit preparation, Protocol implementation, Stakeholder liaison
Preferred skills
Master's degree in relevant field, SOCRA or ACRP certification
Technologies
Internal tracking systems for active INDs/IDEs
Responsibilities
Supervise and lead Clinical Research Coordinators, Ensure compliance with GCP, IRB, and FDA guidelines, Manage study protocol implementation, Develop and implement Standard Operating Procedures (SOPs), Train and onboard new staff, Monitor study progress and troubleshoot issues, Collaborate with Principal Investigators (PIs), Prepare for audits and inspections
Seniority
Manager, hands-on leadership