Clinical Database QA Engineer

4 days ago

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501 - 1000 employees

Founded 1961

Description

• Clinical Database QA Engineer I is responsible for all QA aspects of study build, validation, and maintenance • Act as QA engineer for assigned BeiGene EDC clinical studies • Assist with setting up QA processes and standards • Writing and grooming test case inventory to ensure effective use of testing resources • Familiarity with CDISC standards and experience setting up global libraries • Perform Data Quality reviews • Liaises with the IT and Development groups • Generates and maintains all required documentation • Assist with creation of SOPs, WIs and Templates for QA processes • Troubleshoots issues with EDC • Helps ensure QC of deliverables • Serves on project teams to coordinate and lead QA activities • Attends meetings, participates in discussions, uses an analytical approach to problem solving • Help test external data loads, custom reports, integrations • Support Audit activities

Requirements

• Bachelor’s degree in engineering or science • Fluent in English both for verbal and written • Ability to work independently, under pressure meeting tight deadlines, demonstrating high level of initiative and flexibility • Excellent organizational and analytical skills • High attention to detail and accuracy • Proven problem-solving skills • Demonstrated knowledge of clinical and pharmaceutical drug development process • Experience of clinical databases, clinical data management systems and electronic data capture (EDC) • Knowledge and understanding of clinical database design / study build / data validation and system interoperability • Competent with project management skills • Excellent communication and interpersonal skills • Demonstrated ability to work effectively with internal groups and external partners • Ability to work in a global team environment • Ability to interact effectively with all levels of management

Benefits

• Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness