BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
General Description:
Clinical Database QA Engineer I is responsible for all QA aspects of study build, validation, and maintenance, including QC activities for new and ongoing clinical studies, start-up activities, database revisions, timely resolution of technical issues related to the conduct and closeout of clinical studies. Clinical Database QA Engineer works collaboratively with Database Programmer, Data Manager, and multiple functional groups to complete QC tasks per agreed upon timelines. Partner effectively with other CDM Systems staff to seamlessly ensure high quality deliverables such as EDC platform upgrades, EDC architecture design, integrations with internal and external clinical systems, custom report testing, and other clinical data management activities related to the use of electronic data capture technology.
Essential Functions of the job:
• 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 affective 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 to ensure tight communication, adequate support and quality deliverables
• Generates and maintains all required documentation, including specification versions, test summary reports and validation efforts, in support of database build and maintenance.
• Assist with creation of SOPs, WIs and Templates for QA processes.
• Troubleshoots issues with EDC, working with the EDC vendor as needed
• Helps ensure QC of deliverables related to study setup and maintenance in accordance with ICH-GCP, SOPs and standards.
• Serves on project teams to coordinate and lead QA activities for clinical programming projects
• Attends meetings, participates in discussions, uses an analytical approach to problem solving with a focus on quality deliverables
• Help test external data loads, custom reports, integrations
• Support Audit activities
• Working
Computer Skills: Advanced
Other Qualifications:
• 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
Travel: None to Minimal
Education Required:
• Bachelor’s degree in engineering or science
BeiGene Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
BeiGene is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeiGene Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.