Project Manager - RTSM
Core
Lead client meetings and training sessions to deliver an effective, user-friendly Randomization & Trial Supply Management (RTSM) system for clinical study end-users.
Role type
Senior Project Manager (Clinical Trial Systems)
Builds
RTSM modules, User Requirements Specifications (URS), Communication Manuals, and system setups for clinical trials.
Domain
Life Sciences / Clinical Trial Management Systems (CTMS)
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure
Required skills
Project management, protocol review, deliverable coordination, timeline management, troubleshooting, technical advice, Tier 3 on-call support, independent work, problem-solving, detail orientation, verbal and written communication, presentation skills, Microsoft Office proficiency.
Preferred skills
RTSM/IRT/IVRS/IWRS/IXRS knowledge, FDA E6/E8/21 CFR Part 11 knowledge, Subject Randomizations and Clinical Trial Material lists knowledge, Audit Preparedness, Google Docs.
Responsibilities
Review protocols and include required modules in the User Requirements Specification (URS); Create, review, coordinate, and manage deliverables including timelines, KOM, URS, Communication Manual, Requirements for Subject Randomizations, and Clinical Trial Material Lists; Ensure established timelines are met; Facilitate and troubleshoot issues associated with managing the delivery of RTMS systems; Provide technical advice and assistance to other project managers, developers, validation, and customer support staff; Responsible for Tier 3 on-call coverage (24/7/365).
Seniority
Mid-level, hands-on IC
