IRT Test Analyst - Remote Position

Sharp Services, LLC; Bethlehem (Northampton County); Remote; USD 70,000 - 90,000; Full time

Job summary

Sharp Services, LLC is seeking an IRT Test Analyst in Bethlehem, PA to design and execute test plans for the IRT System and project-specific configurations. You will document and track errors through resolution and serve as SME for software testing within regulated environments.

Ideal candidates have a degree or equivalent experience, 3+ years in CRO/pharma testing, and knowledge of HIPAA, GDPR, and 21 CFR Part 11. The role requires strong communication and QA process involvement.

Qualifications

• Bachelor’s degree or equivalent work experience.
• 2-3 years’ experience in a quality management or testing role.
• 3+ years’ experience in CRO/pharma clinical research with IRT, EDC, or ePRO systems.
• Knowledge of HIPAA, GDPR and 21 CFR Part 11.
• Familiarity with GAMP 5 and regulatory documentation practices.

Responsibilities

• Write and execute test plans and test cases for IRT System configurations.
• Document and track system/configuration errors through resolution.
• Create testing summaries and coordinate with the Project Manager on resolutions.
• Communicate testing status to project team and maintain testing documentation.
• Assist in audits, regulatory investigations, and quality events as defined by SOPs.

Skills

Software testing

Communication

SQL

XML Web services

SFTP

SAS

Microsoft Office

Education

Bachelor’s degree or equivalent

Tools

Jira

Job description

## IRT Test AnalystApplylocations: Bethlehem, PA: Rhymney - Field/Home Basedtime type: Full timeposted on: Posted Yesterdayjob requisition id: JR32324The IRT Test Analyst will use software test methodologies to write and execute test plans and use cases related to the functionality of the IRT System and project specific configuration and custom coding. The Test Analyst will be responsible to document and track system or configuration errors through resolution.**Essential Duties and Responsibilities**The IRT Test Analyst is responsible for the testing of project specific study configurations and protocol amendments within the IRT System and versioned releases of the IRT Core System. The IRT Test Analyst will be expected to serve as primary subject matter expert (SME) for software testing.* Write Test Plans in accordance with GAMP 5 and software methodologies.* Create use and/or test cases based off the requirements specifications and test plan.* Execute approved test cases.* Maintain issues log of errors noted during test execution.* Create testing summary at the end of test execution, and work with IRT Project Manager on resolution plan.* Communicate status of testing to the project team.* Maintain Testing Documentation.* Review and provide input in requirement specifications, high focus on risk to patient safety and data integrity.* Provide test case and testing documentation peer reviews.* Assist IRT Project Manager with the development of testing timelines.* Assist IRT Project Manager with the set-up of Client Acceptance Testing.* Ensure timely delivery of all project related deliverables, escalate any risk to the timelines to the IRT Project Manager.* Assist in the maintenance of the IRT Project File.* Understand and adhere to Standard Operating Procedures (SOP) and Work Instructions (WI)* Contribute SME knowledge as applicable to create/update Standard Operating Procedures (SOP)* Prepare for and participate in internal/external audits and regulatory investigations.* Participate in Quality Investigations.* Initiate Quality Events as defined in Standard Operating Procedures.**Qualifications**To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.Required Skills:* Experience with and demonstrated understanding of computer systems and software application implementation including knowledge of software development life cycle.* Strong communication skills, job requires communication with internal stakeholders and vendors.* Basic knowledge of SQL, XML Web services, sFTP and SAS.* Working knowledge of personal computers and Microsoft Office Products, including Word, Project, Excel and Power Point.Required Experience:* Bachelor’s degree or equivalent work experience.* 2-3 years’ experience in a similar quality management or testing role.* Must have 3+ years’ experience working at a CRO or pharmaceutical company on clinical research and development projects with experience using IRT, EDC, or ePRO Systems.* Knowledge of clinical research industry, standard practices and GHC, ICH/GCP guidelines and FDA Regulations.* Knowledge and understanding of regulations associated with clinical trial data handling, including HIPAA, GDPR and 21 CFR Part 11.