Project Manager - RTSM
Core
Lead client meetings, training sessions, and system setup for Randomization & Trial Supply Management (RTSM) modules to deliver effective systems for clinical study end-users.
Role type
Senior IC Project Manager (Clinical Trials)
Builds
User-friendly RTSM systems for clinical studies
Domain
Life Sciences / Clinical Trials
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
RTSM experience, Protocol review, User Requirements Specification (URS) creation, Timeline management, User Acceptance Testing (UAT), System setup, Tier 3 on-call support, Technical advice to developers/validation/support
Preferred skills
RTSM/IRT/IVRS/IWRS/IXRS knowledge, FDA E6/E8/21 CFR Part 11 knowledge, Audit Preparedness, Google Docs
Technologies
Microsoft Office, RTSM modules
Responsibilities
Review protocols and include required modules in URS; Create, review, and coordinate deliverables including timelines, KOM, URS, Communication Manual, and Clinical Trial Material Lists; Ensure established timelines are met; Facilitate and troubleshoot issues associated with RTSM system delivery; Provide technical advice to project managers, developers, validation, and customer support staff; Provide Tier 3 on-call coverage (24/7/365)
Seniority
Mid-Senior, hands-on IC
