RTSM Technical Project Manager/Business Systems Analyst Level I - Amendments (Hybrid Role)

Brief Description

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 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.
• Software implementation and testing experience required in clinical research or supply chain related industry is preferred. Project management experience working with cross-functional business and technical teams as project lead is also preferred.
• 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.

Summary

4G Clinical is honored to be part of Fast Company's 2020 Best Workplaces for Innovators list, citing businesses and organizations that demonstrate a deep commitment to encouraging innovation at all levels. 4G Clinical came in at #8 for its dedication to building a culture that fuels innovation, curiosity, and the spirit of experimentation in all facets of the business from product development and brand to services and staffing. We were also voted one of the 2018 Best Places in Health Care & Biopharma by Great Place to Work® and FORTUNE.

About Us

4G Clinical is a global leader in randomization and trial supply management (RTSM) and supply forecasting optimization software for the life sciences industry, offering the only fully cloud-based, 100% configurable and flexible solutions utilizing natural language processing (NLP) to accelerate clinical trials. 4G Clinical is headquartered in the Boston Biotech corridor of Wellesley, MA, with offices in Europe and Asia.

For U.S.-based candidates, we offer compelling benefits to our employees, including:

• Health, dental, and vision benefits
• Unlimited Vacation Days for Salaried Full-time Employees
• FSA and Dependent Care Accounts
• Company Paid Disability and Life Insurance
• Global mental health benefit
• Generous 401k program
• Paid sabbatical program
• Option Grants
  
  

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.