eCOA UAT Test Lead

Full time Full day
Durham, NC

Job Overview:

eCOA UAT Test Lead

  • Proactive follow-up with Sponsor and Third Party Vendor to ensure comprehensive understanding of study design and technology design with a view of providing quality deliverables.

  • Active participation in study team meetings.

  • Review and provide input on requirements and specifications.

  • Manage UAT plans and timelines, ensuring that team members adhere to the schedules and timetables for the completion of projects.

  • Responsible for creation of UAT Test Plan and UAT Test Scripts, directing the execution of the test scripts, manage defect tracker leading eventually to system go-live for initial and post production releases.

  • Respond to and solve technical oriented problems as appropriate.

  • Lead meetings with stakeholders to present UAT material.

  • Ability to guide/instruct participants during the execution of User Acceptance Testing (UAT) and system integration testing.

  • Collaborate with both Sponsor and their external vendors, and internal team members to develop scenarios for testing purposes



  • Bachelor's Degree in life science, computer science, engineering, business or related discipline

  • Minimum 2-4+ years of experience in clinical systems such as CTMS, ePRO, IXRS, EDC or an equivalent combination of education and experience to successfully perform the key responsibilities of the job

  • Proficiency in converting complex technical and business requirements into an understandable UAT Test Plan and UAT Test Scripts.

  • Experience with clinical systems such as CTMS, eCOA, EDC or other related technology in pharmaceutical/biotechnology industry.


  • Create and Execute validation test scripts and document the test results.

  • Plan and establish timelines to meet or exceed client expectation for validations.

  • Review clinical project specification documentation to create appropriate testing methodologies.

  • Act as Subject Matter Expert (SME) and be point of contact for any technical services, issues related to Validation process.

  • Write and review validation documentation to support projects.

  • Work with other team members to create appropriate testing environments to support testing methodologies.

  • Conduct Peer Review/Quality control of study design for assigned projects

  • Utilize strong working knowledge of SOPs, validation standards, and work procedures to suggest potential improvements and to provide training and guidance to all critical staff.

  • Assist in the support of regulatory and client audits of validation activities and documents.

  • Understand implications of activities on project budgets.

  • Train, Mentor and support the team in their understanding and adoption of validation concepts and responsibilities.

  • Active member of SOP review team as assigned.

  • Lead or assist with special projects as designated.

  • Perform other duties as assigned by management.

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