Integration Test Analyst

4G Clinical LLC.; Wellesley (MA); Sur place; USD 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

Health, dental, and vision benefits

Unlimited vacation for salaried full‑n

FSA and Dependent Care Accounts

Company paid disability and life

Global mental health benefit

Generous 401k program

Paid sabbatical

Résumé du poste

4G Clinical LLC is seeking a detail-oriented tester to validate our integration solutions supporting clinical studies. You will collaborate with Integrations Leads to ensure high-quality, validated integrations delivered to clients, and develop study-specific test plans and cases.

Ideal candidates have 2+ years in clinical research, familiarity with GCP/21 CFR Part 11, and experience with IRT/RTSM or agile environments. This role involves following SOPs and participating in client audits.

Qualifications

• Minimum 2 years’ experience in clinical research, RTSM/IRT services delivery and eClinical systems implementation.
• Knowledge of US FDA GCP and ICH GCP regulations, 21 CFR Part 11 and EU Annex 11.
• Software testing experience is a plus.
• Experience with IRT/RTSM and Agile development is a plus.

Responsabilités

• Testing of Company’s proprietary Integration solutions in support of the client’s study.
• Collaborate with Integrations Leads to ensure integration builds are tested appropriately to deliver a high quality, validated integration to clients.
• Develop study-specific integration validation plans, test strategies and test cases.
• Execute integrations testing, following 4G Clinical SOPs.
• Participate in client audits.

Connaissances

Clinical research experience

GCP/ICH knowledge

Software testing

IRT/RTSM experience

Agile experience

Formation

Bachelor's degree in life sciences / supply chain / IT

Description du poste

Brief Description

• Testing of Companies proprietary Integration solutions in support of the client’s study.
• Collaborate with Integrations Leads to ensure integration builds are tested appropriately to deliver a high quality, validated integration to clients.
• Responsible for operational testing required for integrations applications (initial build / post go live changes) as per 4G Clinical SOPs:
• Responsible for integration level validation to ensure integration is developed, tested and deployed as per 4G Clinical SOPs.
• Work with Integrations Leads to identify and understand integration customizations, if any, to ensure that a risk assessment can be properly conducted as per 4G Clinical SOPs and that the integrations testing strategy reflects this.
• Develop study-specific integration validation plans, test strategies and test cases.
• Execute integrations testing, following 4G Clinical SOPs.
• Participate in client audits.

Requirements

• 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.
• 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.
• Software testing experience is a plus.
• Experience with IRT/RTSM is preferred.
• Experience working with agile development methodology is a plus.

Education And/or Certification Requirements

• The candidate must possess at minimum a bachelor’s degree in a life sciences, 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

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.