What are the responsibilities and job description for the Technical Project Manager/Business Systems Analyst (Hybrid Role) position at 4g Clinical, LLC?
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
- 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.
