Description

Description

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.

We are currently seeking a talented individual to join our team as a Business Systems Analyst. You'll be at the forefront of driving system implementation and operations, playing a vital role in the success of our client projects.

Key Accountabilities of the Technical Project Manager/Business Systems Analyst include 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 RTSM/IRT services delivery and eClinical systems implementation, or over 7 years of relevant system implementation experience in a related industry.
• 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 a life science, supply chain management, or information technology field, or equivalent experience.

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

Requirements

• Native-level Japanese skills required
• Business Level English skills required