Job summary:
Data quality analysts are responsible for examining complex data for quality of the data being collected, facilitate resolution of data quality issues, and deliver clean data sets to sponsors.
Major responsibilities:
Review specification material needed to conduct clinical data management activities such as data management plans, data transfer agreements, image review charters, etc.
Perform quality review of test transfer outputs and verify compliance with project specification material prior to external delivery
Develop quality control templates and support tools to verify the data in programmed outputs are accurate and formatted per sponsor specification requirements
Participate in user acceptance testing (uat) and data quality control review of data outputs generated in both automated and manual fashions to verify the integrity of the data generated
Perform ongoing data reconciliation and facilitate tracking issues identified, triaging resolution requests to the responsible parties, and verifying resolution actions have been completed as appropriate throughout study conduct and close-out
Review and cross-check deliverable outputs against project documentation and original data origins to ensure data are accurate and being delivered per the project requirements and sponsor specifications
Qualifications:
Education
Bachelor’s degree in computer science, life sciences or related field preferred, or equivalent experience required
Experience
2-4 years of experience in clinical data management, site monitoring or related experience
Working knowledge of the clinical drug development process, fda regulatory requirements, ich, gcp and 21 cfr part 11 guidelines, cdisc sdtm standards, and data management industry standard practices
Microsoft excel proficiency requiredSql experience a plus
Experience performing user acceptance testing in a clinical data management setting
Attention to detail, as well as strong organizational, communication, and time management skills
Oncology and/or neurology experience preferred
What we offer
Competitive salary
401k with generous matching
Flexible vacation policy
Invicro is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity.