Sr. Specialist, Clinical Trials
Core
Leads operational activities for planning, initiation, conduct, and close-out of domestic and global clinical studies, serving as a lead on smaller studies or a team member for assigned studies.
Role type
Senior Specialist, Clinical Trials Operations
Builds
Clinical studies (domestic and global) using CROs and internally run studies
Domain
Biopharmaceuticals / Clinical Drug Development
Deliverable
client delivery
Required skills
Clinical trial operations management, CRO/vendor management, FDA/ICH/GCP regulatory compliance, study timeline creation, recruitment support, monitoring plan development, data analysis, project management
Preferred skills
Master's degree in a scientific field, experience with lower-level specialist training
Technologies
None explicitly stated
Responsibilities
Partner with Clinical Trial Managers to ensure regulatory compliance; manage project plans and track metrics for CROs and contract service providers; participate in study team meetings and create study timelines; document standard processes and train lower-level specialists; participate in onsite monitoring and co-monitoring visits for internal studies
Seniority
Senior, hands-on IC
