RTSM Technical Project Manager/Business Systems Analyst (Hybrid Role)

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. With preferred locations in Mexico, 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

• Partner closely with Solutions Engineer in support of implementation of client RTSM applications to enable client start-up targets
• Attend client meetings and design sessions, with the ability to suggest solutions for client problems, and relay information from meetings
• Log, track and drive resolution of functional and technical issues discovered during implementation and prior to go-live
• Ensures adherence to required deliverables and milestones of Project Management SOPs and WIs
• Partner with Solutions Engineer to drive resolution of functional and technical issues discovered during implementation and prior to go-live.
• Drive project specific validation activities including Build Verification Testing, Validation Testing, system setup and implementation activities.
• Develops and executes scripts for testing.
• Develop client and site-facing training materials during study implementation
• Develop and keep up to date study timeline using Project Management Tracker and JIRA projects, ensuring internal teams are in alignment

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