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Raleigh, North Carolina, United States
Remote only
Position Overview:
The Project Manager is the primary client interface for client implementations, from initial engagement to study closedown. Project Managers are responsible for managing projects through the software development lifecycle and through study maintenance while working collaboratively with teammates and maintaining exceptional client satisfaction.
As a Project Manager, you are the primary point of contact for our clinical trial sponsor and CRO clients from the moment their Randomization and Trial Supply Management (RTSM) system goes live through the life of the study. You own the day-to-day client relationship, the project plan, and the coordination across internal teams needed to keep the trial's randomization and drug supply operations running smoothly.
This is a delivery and relationship-management role, not a system-build role: you inherit a validated, go-live-ready RTSM system from the BSA and study build team, and you are accountable for everything that happens with that system in production — change requests, user management, ongoing supply strategy conversations, issue triage, and study close-out.
*This position can be based remotely within the US.
Serve as the single point of contact for the client (sponsor/CRO) for all RTSM-related activities post go-live, building trusted, long-term relationships across the life of the study.
Lead recurring client status calls and steering committee meetings; own the agenda, minutes, and action item tracking.
Manage the end-to-end change control process for live systems: intake change requests, scope impact, coordinate with Design/Build, QA, and Biostatistics, and drive changes through validation and deployment.
Own the project plan, timeline, and RAID (risks, actions, issues, decisions) log for each assigned study post go-live.
Coordinate site and depot user provisioning, training refreshers, and access issues in partnership with the Help Desk and Training teams.
Monitor drug supply forecasting, inventory thresholds, and resupply strategy conversations with the client, escalating operational risk proactively.
Manage study amendments (protocol amendments, dosing changes, new sites/countries, IP updates) from client request through implementation.
Coordinate UAT (user acceptance testing) for any post-go-live system changes with the client and internal build teams.
Track and communicate study metrics (enrollment, randomization, supply status) to the client and internal leadership.
Own financial tracking for the account, including change order scoping, budget tracking, and invoicing coordination with the client and internal finance.
Lead study close-out activities: final reconciliation, system decommissioning, archival, and lessons-learned reviews.
Act as the internal advocate for the client, partnering with Sales, Design PM, Programming, QA, and Regulatory to resolve issues quickly.
Maintain audit-ready documentation in accordance with GxP, 21 CFR Part 11, and internal SOPs
Strong attention to detail and quality-focus
Strong customer service orientation
Excellent organizational and time management skills
Good communication skills
Excellent organizational skills
Strong interpersonal skills with the ability to work effectively with a wide variety of professionals
Able to work on multiple assignments with moderate supervision
