Clinical Trial Registration Manager II
Core
Drives processes for assigned protocol registration activities to ensure timely, high-quality information is posted on clinical trial registries (Clinicaltrials.gov, EU PAS, local registries) in adherence to NIH guidelines.
Role type
Senior IC Clinical Trial Registration Manager
Builds
Accurate and updated clinical trial registry entries
Domain
Biopharmaceuticals / Clinical Operations
Required skills
Clinical trial protocol registration, NIH guidelines compliance, Clinicaltrials.gov management, EU PAS management, Local registry management, Stakeholder liaison, Process quality monitoring, Continuous improvement initiatives, Risk identification and escalation, Team coaching and mentorship
Preferred skills
None stated
Technologies
Clinicaltrials.gov, EU PAS, BMS Clinical Trial Management System
Responsibilities
Drive processes for assigned protocol registration activities; Liaise with clinical team reviewers and stakeholders to ensure trial registrations are accurate and consistent; Maintain studies registered on Clinicaltrials.gov; Maintain study trackers; Serve as SME by educating stakeholders on NIH review criteria; Support continuous improvement initiatives; Participate in identifying and addressing risks related to non-compliance; Support the development of team and cross-functional expertise.
Seniority
Senior, hands-on IC