eCOA UAT Test Lead
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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