RTSM Technical Project Manager - Level I

4G Clinical is a global leader in cloud-based randomization and trial supply management software for the life sciences industry. The RTSM Technical Project Manager - Level I supports system implementations, configuration changes, validation, testing, integrations, and client user acceptance activities, while also assisting with operational support and audits.

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
• Reviews and understands change impacts and risks with project leads to focus project testing efforts accordingly
• 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
• Supports project validation activities including testing, 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:

• 1-3 years of experience in the clinical research field
• RTSM/IRT services delivery and eClinical systems implementation
• Software implementation and testing experience required in clinical research or supply chain related industry
• Project management experience working with cross-functional business and technical teams as project lead is required
• The candidate must possess at minimum a bachelor's degree in a life science, supply chain management, or information technology field, or equivalent experience
• 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