- 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.
What we expect of you We are all different, yet we all use our unique contributions to serve patients. The vital attribute professional we seek is a [type of person] with these qualifications.
Basic Qualifications:
- Master s degree and 1 to 3 years of life science, computer science, business administration or related discipline or equivalent experience OR
- Bachelor s degree and 3 to 5 years of life science, computer science, business administration or related discipline or equivalent experience OR
- Diploma and 7 to 9 years of life science, computer science, business administration or related discipline or equivalent experience
- General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or clinical research organization (CRO) company)
Preferred Qualifications Must-Have 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
Good-to-Have Skills:
- 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
Soft Skills:
- Excellent communication and collaboration skills.
- Detail-oriented with strong analytical and problem-solving abilities.
- Ability to work independently and as part of a team.