Poxy Clinical, LLC IRT UAT Manager Cambridge, MA · Remote · Full time

Poxy Clinical is looking for an Interactive Response Technology (IRT), User Acceptance Testing (UAT), Manager to join our growing services team. The IRT UAT Manager uses technical, industry and interpersonal skills to develop and oversee the execution of UAT Plans for IRT supported clinical trials. This includes but is not limited to performing quality reviews of the User Requirements Specification and Study Protocol, creation of Test Scripts, and any other User Acceptance Testing deliverables during this testing phase. The IRT UAT Mgr. will lead and train testers on UAT execution, and occasionally perform test execution on behalf of the Sponsor. Other responsibilities will extend to validation related activities on quality management systems and ancillary clinical trial technology i.e., supporting clinical supply technology on test needs.

Description

PRIMARY RESPONSIBILITIES:

  • Provide UAT scoping within required timelines based on an analysis of study and system design
  • Identify study customizations required and if any conduct impact assessment
  • Quality reviews of the User Requirements Specification and Study Protocol
  • Create UAT Plan, and ensure completeness of test scripts
  • Identify business requirements, functional design, process design (including scenario design, flow mapping), testing, training, defining support procedures and supporting implementations
  •  Complete all UAT deliverables, following the UAT process as defined within the company
  • Train sponsor / CRO testers, and vendor staff as applicable in UAT execution.
  • Provide excellent UAT execution support and resolution management to close-out -- including logging, tracking, and driving UAT finding and root cause analysis, and any CAPAs required.
  • Create UAT 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
  • Complete vendor qualification activities, including completion of vendor questionnaire, and participate in vendor audits.
  • 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 IRT 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 5+ years industry experience
  • 5-8 years’ experience as a business analyst or in a client facing / technical role
  • 3-5 years’ experience with IRT / RTSM services delivery and systems implementation
  • Experience working in a regulated environment, FDA highly preferred
  • 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, GAMP guidance, and computer software validation (CSV)

 

PHYSICAL REQUIREMENTS & OTHER:

  • Prolonged periods sitting at a desk and working on a computer
  • Must be able to lift up to 15 pounds at times
  • Proficient in Microsoft Office Suite or related software program
  • Must have office desk, home office set-up -OR- work from office full time