Project Manager - REMS Team - Remote based in the US
Core
Lead cross-functional teams to deliver full-service clinical trials and Risk Evaluation and Mitigation Strategies (REMS) projects, ensuring quality, time, and cost objectives are met for pharmaceutical sponsors.
Role type
Senior Project Manager (Clinical Trials/REMS)
Builds
Clinical trial deliverables and REMS compliance programs
Domain
Life Sciences / Clinical Research / Regulatory Affairs
Required skills
Clinical trial management, REMS program management, Cross-functional team leadership, Financial stewardship, Risk identification and issue resolution, Contract negotiation, Regulatory compliance (ICH-GCP), Strategic thinking
Preferred skills
Advanced therapeutic area knowledge, Experience with CTMS/Preclarus/Clarity systems, Cross-cultural awareness
Technologies
Microsoft Office Suite, CTMS, Preclarus, Clarity
Responsibilities
Serve as primary contact between sponsor and organization, Manage project budget and resource alignment, Drive risk identification and issue resolution, Ensure team compliance with SOPs and regulatory requirements, Establish and manage customer expectations, Lead secondary project leads when scope requires
Seniority
Senior, hands-on IC