Department: Clinical Informatics
Reports To: Lead Clinical Database QA Engineer, Clinical Informatic
Bachelor’s degree in engineering or science and 3+ years of relevant experience in EDC QA Process
Clinical database QA engineer 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. Lead clinical database QA Engineer works collaboratively with Clinical Informatics, Data Management and multiple functional groups to complete QC tasks per agreed upon timelines.
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
- Liases 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 with other QA members to develop and promote best practices across multiple study teams
- Provide mentorship to 1-3 Junior QA resources
Ethics – Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Planning/Organizing – Prioritizes and plans work activities; Uses time efficiently. Completes tasks correctly and on time. Follows instructions and responds to management direction.
Communication – Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
Teamwork – Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone’s efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.
Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
Technical Skills – Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
Dependability – Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Quality – Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical – Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
Project Management – Communicates changes and progress; Completes projects on time and budget.