Project Manager
Endpoint Clinical· Client Services
RemoteF - Full TimePosted 4mo ago
About the role
The Project Manager is the primary client interface for client implementations, overseeing projects through the software development lifecycle and study maintenance, with a focus on delivery and relationship management for RTSM systems in clinical trials.
Responsibilities
- 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.
Qualifications
- 2+ years of Project Management experience in clinical trials, RTSM/IRT, clinical supply chain, or a related life sciences/technology field
- 2-4 years’ experience in the life science industry
- Previous experience working in a fast-paced, entrepreneurial environment preferred
- Familiarity using SQL a plus
Skills
Required:Attention to detailCustomer serviceOrganization & time managementCommunicationInterpersonal skillsMulti-tasking
Nice to have:SQL
Last updated Oct 21, 2026. Interested? Apply on the company site.
About Endpoint Clinical
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