Rubrik:

Produkter:

Roller:

Testledare

Distrikt:

Gbg

Beskrivning:

The Quality Assurance Lead – Study Onboarding is responsible for leading the validation and testing activities related to development and the support of clinical studies using Unify, a clinical trial solution co-designed by patients, healthcare professionals, and Evinova to streamline the trial experience and digitize clinical trials. Working closely with the Study Onboarding team and the BA team, the Quality Assurance Analyst analyses the onboarding scope and its impact on new studies, defines test coverage, and ensures the overall quality of the studies. Effective communication and cultural sensitivity are key, as the role requires interactive collaboration. Additionally, the Quality Assurance Lead leads the process and workflow improvements to enable scalability and support a growing number of clinical trials. Overview of responsibilities The Quality Assurance Lead as part of the Configuration Verification Test team is expected to perform at Seniority level in the following: • Team Leadership: Take full ownership of the quality of the new study during the onboarding phase, ensuring the delivery of a high-quality product that meets all specified requirements. Be the main person responsible for the successful validation and test of study upgrades, prioritizing ongoing support for the team. In addition, be part of refining and optimizing the onboarding QA process, addressing any process blockers that may arise. Collaborate closely with other teams to facilitate successful releases. • Impact Assessment and Configuration changes Analyses: - Analyse study specifications and collaborate with BA team to understand the scope of the study and its impact on existing studies. Analyse the scope of the study, understand the changes made to the system configuration, and lead the test cases and test coverage process cover the changes delivered during study onboarding. • Validation and Test of the Product Configuration- Plan the execution of test cases and oversee and be part of the testing activities to verify the quality and functionality of study onboarding. • Risk Management - Identify and mitigate risks associated with study upgrades on quality side, proactively addressing potential issues to minimize impact on project timelines and deliverables. • Defect Management – Manage the identification, tracking, and resolution of defects encountered during testing, ensuring timely resolution and communication with relevant stakeholders. • Documentation - Ensure thorough documentation of QA activities, including test plans, test report, traceability matrix and any additional documentation to support project documentation and audit requirements. • Process improvement - Provide feedback on the testing process and suggest improvements to streamline Configuration Verification and Test activities for future study upgrades. Work collaboratively with 1. New Studies Onboarding QA Team – Requirement Analysis, Test Planning, Test Case Design and Execution, Defect Management, and Risk Assessment. Maintain the Onboarding documentation as test plans and test reports. 2. Study Onboarding BA Team – collaboration on requirements analyses and impact assessment on the upgrade. 3. Study Onboarding PM Team – collaborate with the PM team on planning and defect prioritization and upgrade dependencies. 4. SMEs – engineering teams on case analysis and resolution. 5. Product owners and business analysts, to understand existing functionalities. Required skills & experience. • 7+ years of experience in software quality assurance, with 2 years in a leadership role • Solid understanding of quality assurance theory, terminology, and strategies. • Proficiency in test planning, test case design, and test execution. • Experience with test management tools and system such as Xra and defect tracking systems. • Excellent communication and interpersonal skills, with the ability to effectively lead and collaborate with cross-functional teams both technical and non-technical. • Experience in mentoring and coaching team members, providing guidance and support to ensure quality deliverables. • Mobile testing experience • Experience in working with HTTP Proxy Tool • Experience in integration and web-services testing. Desired skills & experience • Experience from Healthcare and Life Sciences, preferably with clinical trials. • Experience of working in a global organisation with complex/geographical context • Experience of working in a regulated environment, ideally, GxP/SaMD experience • Knowledge of automation testing tools and experience supporting automation tests Education/Experience: • Degree in relevant discipline or formal certification in quality assurance practice Location: Sweden, Gothenburg (preferably 3 days in the office)

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