Data Quality Analyst II

What can we offer you?

Apart from job satisfaction, we can offer you:

HEALTH

• Medical, Dental and Vision benefits for you and your family, including Flexible Spending Accounts (FSA)

YOURSELF

• Paid time off policy including holidays and sick time
• Internal growth and development programs & trainings

WEALTH

• 401(k) program, life & accident insurance and disability insurance

Job Purpose

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.

Role 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
• Other duties as assigned.

Education

• Bachelor's degree in Life Sciences or related field preferred, or equivalent experience required

Skills

• 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 required. SQL 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
• Excellent communication and interpersonal skills.