Minimum 2 years of experience in clinical research, focusing on clinical supplies operations and eClinical systems implementation.
Familiarity with US FDA Good Clinical Practice (GCP) and ICH GCP regulations.
Knowledge of Electronic Records and Signatures regulation (21 CFR Part 11) and EU Annex 11.
Software testing experience is advantageous.
Experience with IRT/RTSM services is preferred.
Agile development methodology experience is a plus.
Bachelor's degree in life sciences, supply chain management, or information technology, or equivalent experience.
Responsibilities
Test proprietary integration solutions to support client studies.
Collaborate with Integrations Leads to ensure quality testing of integration builds.
Conduct operational testing for integration applications as per 4G Clinical SOPs.
Validate integration development, testing, and deployment according to SOPs.
Identify integration customizations and conduct risk assessments with Integrations Leads.
Develop study-specific integration validation plans and test strategies.
Execute integrations testing in compliance with 4G Clinical SOPs.
Participate in client audits.
Benefits
Opportunity to work with cutting-edge integration solutions in clinical research.
Collaborative environment with experienced Integrations Leads.
Exposure to client audits, enhancing professional credibility.
Focus on quality assurance and compliance with industry standards.
Full Job Description
Description
The Integrations Test Analyst is responsible for the following:
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.
About 4G Clinical
4G Clinical is a software company that provides cloud-based solutions for clinical trials. The company's platform, Prancer, uses natural language processing and machine learning to automate the design, randomization, and supply chain management of clinical trials. Prancer also provides real-time analytics and reporting to help clinical trial sponsors make data-driven decisions. 4G Clinical was founded in 2015 and is headquartered in Medford, Massachusetts.
