Are you passionate about making a tangible impact in the clinical research field? Do you thrive in dynamic environments where problem-solving and innovation are encouraged? If so, we have an incredible opportunity for you to consider.

The Business Systems Analyst, Amendments is responsible for the following:

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
• 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

• The position requires a minimum of 3 years of experience in the clinical research field, particularly clinical supplies operations, RTSM/IRT services delivery and eClinical systems implementation, or over at least 7 years of relevant system implementation experience in a related industry.
• 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.
• 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.

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