Poxy Clinical, LLC Clinical Systems QA Analyst Remote · Full time

We are currently seeking a skilled Clinical Systems QA Analyst to join our team on a contract-to-hire basis. Joining Poxy Clinical means becoming a part of a dynamic, results-driven team that is continually shaping the future of clinical trials. As a trusted partner for companies conducting clinical trials, we specialize in User Acceptance Testing (UAT) to validate that Randomization and Trial Supply Management (RTSM / IRT) systems are accurate, efficient, and patient-centered. Our aim is to ensure data integrity, patient safety, and speed to market for novel therapies, making us an integral part of the groundbreaking journey from trial to treatment.

Description

The Clinical Systems QA Analyst will use technical, industry and interpersonal skills to author, execute and manage overall UAT or validation projects for clinical system supported clinical trials. Core responsibilities include performing quality reviews of the User Requirements Specification and Study Protocol, creation of Test Scripts, and any other User Acceptance Testing deliverables and Validation projects. They will also oversee testers on UAT execution, and occasionally perform test execution on behalf of the Sponsor. Other responsibilities will extend to validation activities on quality management systems and ancillary clinical trial technology (i.e., supporting clinical supply technology on test needs).  

  

PRIMARY DUTIES / RESPONSIBILITIES: 

  • Provide test scoping within required timelines based on an analysis of study and system design. 
  • Identify study customizations required and if any, conduct impact assessment. 
  • Perform quality reviews of the User Requirements Specification and Study Protocol to determine functional design. 
  • Engage business teams to determine business requirements and conduct gap analysis to ensure requirements are fit for purpose 
  • Create UAT Plan, test scenarios and test cases adhering to business and system specifications.  
  • Complete all project deliverables, following the test process and methodologies as defined within the company SOPs. 
  • Train sponsor / CRO testers, and vendor staff as applicable in UAT execution. 
  • Provide excellent test execution support and resolution management to close-out -- including logging, tracking, and driving UAT finding and root cause analysis, and any CAPAs required. 
  • Create business standards by Sponsors as needed; host and capture any lessons learned. 
  • Comply with company standard operating procedures (SOPs), best practices, and Good Clinical Practice (GCP) and Good Documentation Practice (GDP) standards. 


OTHER RESPONSIBILITIES: 

  • Support business development on proposal bids for RFPs and RFIs. 
  • Support vendor qualification activities as needed 
  • Provide subject matter input on SOPs and other process related documents 
  • Provide support for business operational activities related to UAT process, value proposition, and management of KPI and metrics. 

 

REQUIRED SKILLS & ABILITIES:  

  • Ability to apply Project Management methodologies to advance team and stakeholders to achieve on-time UAT completions towards earlier or agreed timelines. 
  • Capable of working closely in a client-facing role with cross-functional study teams and Clinical System stakeholders. 
  • Ability to follow Poxy’s governance processes, procedures, and applicable compliance standards and guidance. 
  • Knowledge of system implementation methodology: including requirements gathering, design, build, test and deployment, and application of Agile and Waterfall methodologies as they pertain to validation activities. 
  • Have strong prioritization skills and ability to quickly adjust in a dynamic environment, manage multiple UATs and competing priorities with the same level of detail. 
  • Extensive knowledge of Interactive Response Technology (IRT) / Randomization and Trial Supply Management (RTSM). 
  • Demonstration of the ability to take ownership of projects and achieve required deliverables ensuring projects are delivered to the highest quality. 
  • Excellent presentation and verbal/written communication skills, and ability to demonstrate knowledge of the company products and technology to internal and external stakeholders. 
  • Highly motivated, extremely organized with great attention to detail. 
  • Sound problem resolution, judgment, and decision-making capabilities. 
  • Proven ability to take initiative, while being able to adapt and take direction, in a changing environment. 
  • Ability to act as a team player and indirectly lead others and creatively solve problems.  

 

EDUCATION & EXPERIENCE:  

  • Bachelor’s degree in technical discipline (i.e., math, science, engineering, computing); with advanced degree or 3+ years industry experience. 
  • 2-5 years’ experience as a business analyst or in a client facing / technical role. 
  • 2-5 years’ experience with IRT / RTSM services delivery and systems implementation. 
  • Experience working in a regulated environment. 
  • Experience with Software implementation and testing experience in clinical research or a supply chain related industry. 
  • Project management experience working with cross-functional business and technical teams. 
  • Familiarity of cGxP principles, and computer software validation (CSV). 
  • Experience with GAMP principles and application of preferred 

 

PHYSICAL REQUIREMENTS: 

  • Prolonged periods sitting at a desk and working on a computer. 
  • Must be able to lift to 15 pounds at times.   
  • Proficient in Microsoft Office Suite and related software programs. 
  • Must have office desk, home office set-up 

 

We invite candidates who value innovation, collaboration, and the opportunity to contribute to life-changing science to apply. If you're looking for a career that is challenging, fulfilling, and at the cutting edge of healthcare advancement, we'd love to hear from you.  

Salary

$70,000 - $90,000 per year