Endpoint Clinical logo
Endpoint Clinical
Posted 75 days agoVerified live 2d ago

Project Manager

Brief overview

Remote
2+ yrsMinimum
2 green cardsCertified filings
Randomization and Trial Supply Management (RTSM)Clinical TrialsClinical Supply ChainSQLGxP Compliance21 CFR Part 11 ComplianceUser Acceptance Testing (UAT)Change Control ProcessBudget TrackingAudit DocumentationClient Relationship ManagementRisk ManagementProject Management

About the company

Endpoint Clinical logo
Endpoint Clinicalendpointclinical.com

Endpoint Clinical designs, engineers, and tests interactive response technology platforms that enables data access through phones.

Visa sponsorship history

1 year sponsoring, last filed FY2023

Data powered by U.S. Department of Labor. This does not guarantee sponsorship for this specific role.
2PERM certified
Green Card (PERM) FilingsCertified green card filings: a long-term commitment to international hires.
20232
Sponsored employees from
India

Job description

Summary

Endpoint Clinical is an interactive response technology systems provider supporting the life sciences industry. The Project Manager will serve as the primary client interface for client implementations, managing projects through the software development lifecycle and ensuring exceptional client satisfaction.

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

Skills

  • 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
  • Bachelor's degree or equivalent preferred, or appropriate work experience
  • Previous experience working in a fast-paced, entrepreneurial environment preferred
  • Familiarity using SQL a plus

Qualifications

Must Haves

  • 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

Nice to Haves

  • Bachelor's degree or equivalent preferred, or appropriate work experience
  • Previous experience working in a fast-paced, entrepreneurial environment preferred
  • Familiarity using SQL a plus

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