RTSM Technical Project Manager - Level I
- 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.
- Project management experience working with cross-functional business and technical teams as project lead is also preferred.
- Software implementation and testing experience required in clinical research or supply chain related industry is preferred.
- 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 is a plus.
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