DescriptionKey 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 and to enable client start-up targets 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
- Drive project specific validation activities including Build Verification Testing, Validation Testing, system setup and implementation activities.
- Supports project validation activities including testing, setup, and implementation activities
- Develops and executes scripts for testing
- 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.
- Participate in client audits as needed.
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 SOPsRequirements- The position requires 1-3 years of experience in the clinical research field.
- RTSM/IRT services delivery and eClinical systems implementation.
- 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 RequirementsThe candidate must possess at minimum a bachelor's degree in a life science, supply chain management, or information technology field, or equivalent experience.
