System Implementation

• Partnering closely with project leads in support of the implementation of configuration changes 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
• 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

System Operations

• 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.

Required Experience

• For this position, a minimum of 3 years of experience in the clinical research field, particularly clinical supplies operations, RTSM/IRT services delivery and eClinical systems implementation is preferred, or at least 7 years of relevant system implementation experience in a related industry.
• Software implementation and testing experience in clinical research or supply chain related industry is preferred. Project management experience working with cross-functional business and technical teams as project lead is also 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.

Education and/or Certification Requirements

The candidate must possess at minimum a bachelor’s degree in an information technology, life sciences, or supply chain management field. Equivalent experience in these or related fields may also be considered.