RTSM Technical Project Manager - Level I

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 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 SOPs.

Requirements

• 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 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.

We offer compelling benefits to our international and US-based employees. Benefits vary by region and should be discussed with a 4G Talent Acquisition or HR representative.

4G Clinical is proud to be an Equal Opportunity Employer, and it is foundational to how we recruit and hire our talented team. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by applicable law.