RTSM Technical Project Manager - Level I

4G Clinical is a global leader in randomization and trial supply management (RTSM) and supply forecasting optimization software for the life sciences industry. They are seeking a Technical Project Manager to support the implementation of their PRANCER technology, manage client interactions, and oversee system operations and validations.

Responsibilities:

• Partnering closely with project leads in support of the implementation of configuration changes and to enable client start-up targets to 4G Clinical’s PRANCER technology
• Attend client meetings and design sessions as appropriate
• Support logging, tracking and resolution of functional and technical issues discovered during implementation and prior to applying changes to production
• Ensures adherence to required deliverables and milestones of Project Management SOP
• Drive project specific validation activities including Build Verification Testing, Validation Testing, system setup and implementation activities
• Develops and executes scripts for testing
• Supports changes to integrations, including implementing changes to integration specifications
• Assist with client user acceptance testing (UAT) activities
• Serve as Customer Support point of escalation for any system or support issues where required; assist with creation of training materials
• Maintain issue logs for builds or validation activities of the RTSM
• Participate in client audits as needed

Requirements:

• Project management experience working with cross-functional business and technical teams as project lead
• Software implementation and testing experience required in clinical research or supply chain related industry
• Knowledge of US FDA Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) GCP regulations, Electronic Records; Electronic Signatures regulation (21 CFR Part 11) and EU Annex 11
• Bachelor's degree in a life science, supply chain management, or information technology field, or equivalent experience