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