RTSM Technical Project Manager - Level I

Key Accountabilities

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

At all times, employees are expected to adhere to company policies and company SOPs.

Requirements

• 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 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.

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.

Benefits

• 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