RTSM Solutions Architect - New Build/Amendments
Summary
Implements configuration changes, new builds and amendments on 4G Clinical's PRANCER RTSM platform for clinical trials: defining and managing project scope, preparing technical environments for UAT and production, and coordinating validation and integration teams. Requires clinical research and regulatory expertise (GCP, 21 CFR Part 11, EU Annex 11).
The Client Services Lead is responsible for the following:
System Implementation
- Expert implementation of configuration changes to 4G Clinical’s PRANCER technology, including:
- Primary responsibility for defining and managing project scope and implementing technical changes within agreed timelines and at the highest quality
- Partner with 4G Clinical Support Leads to manage the client relationship and ensure successful project implementation
- Provide change design consultation assistance to 4G Clinical Support Leads during ‘discovery’ phase, prior to formal project request or start-up
- Partner with 4G Clinical Validation team to complete project validation, ensuring study changes are fully tested, and related risk areas are regression tested
- Partner with 4G Clinical Integration team to ensure that required integration changes are correctly defined, tested and implemented
- Escalate mid-project scope changes to 4G Clinical Accounts team to ensure that associated client costs are appropriately assessed and managed
- Prepare all technical environments for internal and client use, including client UAT and production change implementation
- Ensure that required patient data changes in support of the system changes are defined, scripted and tested
Product Development
- Identify opportunities for product enhancements and collaborate with product development to influence RTSM product feature development, prioritization, and strategy to ensure that the product meets client capability needs, improve the system’s efficiency and user-friendliness
This JOB description should not be deemed all-inclusive. Additional requirements and expectations may be assigned. At all times, employees are expected to adhere to company policies and company SOPs
- A minimum of 5 years of experience in the clinical research field, particularly clinical supplies operations, RTSM/IRT services delivery and eClinical systems implementation is preferred.
- The following skills are essential: knowledge 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 and associated regulatory guidance documents.
Education and/or Certification Requirements
The candidate should possess at minimum a bachelor’s degree in a life sciences, supply chain management, or information technology field, or have equivalent experience.
