4G Clinical has an exciting opportunity available for an experienced Software Test Analyst supporting projects in the clinical research field. At 4G, you have the opportunity to thrive personally and professionally, make a real impact in the lives of others, and be part of a culture where individuals are valued for their perspectives, ideas, and contributions.

We strongly prefer this position to be based in Wellesley, MA with a hybrid in-office work schedule but are open to candidates working out of Raleigh/Durham, NC for the right candidate.

WHAT YOU WILL DO (RESPONSIBILITIES)

The Software Test Analyst is responsible for the following:

1. System Implementation

• Testing of client Randomization and Trial Supply Management (RTSM) applications to enable client start-up targets.
• Work with Client Services Leads (CSLs) to ensure study level applications are tested appropriately to deliver a high quality, validated system to clients. Responsible for project level validation to ensure study application is developed, tested and deployed as per 4G Clinical SOPs.
• Work with CSLs to identify study customizations required, if any, to ensure that an impact assessment can be properly conducted as per 4G Clinical SOPs and that the study testing strategy reflects this.
• Develop study specific validation plans, test strategies and test cases.
• Execute study testing, following 4G SOPs.
• Develop study specific validation reports.
• Develop client and site system training manuals.
• Prepare our RTSM system, known as Prancer RTSM®, for UAT and production, in coordination with the development team as necessary.

2. System Operations

• 
  Provide support to CSLs for day-to-day operations in support of RTSM applications.
• Responsible for operational testing required for study applications (system / data changes) as per 4G’s SOPs.
• Develop training materials and train Customer Support staff on study application support procedures and client standards.
• Participate in client audits.

3. Product Development

• 
  Identify operational business needs and collaborate with product development to influence RTSM product feature development, prioritization and strategy to ensure that the product meets client capability needs and to improve the system’s efficiency and user-friendliness.

REQUIRED / PREFERRED SKILLS

• Required Skills: The position requires a minimum of 2 years’ experience in the clinical research field, particularly clinical supplies operations, RTSM/IRT (Interactive Response Technology) services delivery and eClinical systems implementation.
• Preferred Skills: 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, and associated regulatory guidance documents.

EDUCATION REQUIREMENTS

• The candidate must possess at minimum a bachelor’s degree
• Educational background in life science, supply chain management, or information technology field, highly preferred

ABOUT 4G CLINICAL

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

• 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.