Perform database testing to ensure the integrity and accuracy of data.
Maintain comprehensive database testing documentation.
- Develop detailed edit check test specifications.
- Conduct UAT for edit checks to ensure they meet the required standards.
- Communicate and call out day-to-day issues and risks regarding the area of work.
- Assist with preparation for inspections and provide responses to questions and findings from regulatory authorities and other audits.
- Participate in data management and cross-functional working groups, including global network representation.
- Promote and advocate for data management standard methodologies internally and externally.
Basic Qualifications & Experience:
- Master's degree and 3 to 4 years of life science, computer science, business administration or related discipline or equivalent experience OR
- Bachelor's degree and 5 to 6 years of [life science, computer science, business administration or related discipline or equivalent experience OR
- Diploma and 9 to 10 years of [Job Code's Discipline and/or Sub-Discipline] experience
- General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or clinical research organization (CRO) company
Skills:
- Proficiency in database testing and edit check UAT
- Familiarity with testing and validation plans
- Proficient in testing documentation standard methodologies
- Knowledge of Good Clinical Practice
- Understanding of clinical data management processes
- Familiarity with electronic data capture (EDC) systems and data management plans (DMP).
- Familiarity in inspection readiness
- Familiarity of database audit trails
- Familiarity of Trial Master Files
