FDA CDISC Clinical Data Specialist (SDTM/ADaM)

CTIS, Inc.; Rockville (MD); On-site; USD 110,000 - 140,000; Full time

Job summary

CTIS is seeking a Clinical Data Specialist / Functional Business Analyst – Expert to support FDA CDER/OCS study data management and data quality activities. The ideal candidate will have hands-on experience with clinical study data processing, validation, loading, curation, and issue resolution, along with strong knowledge of FDA regulatory data requirements and CDISC standards.

Experience with SEND and nonclinical study data is highly preferred.

Qualifications

• Hands-on experience in clinical study data management, data operations, or regulatory data.
• Strong knowledge of CDISC standards, including SDTM and ADaM.
• Experience with SQL, SAS, or similar data analysis and validation tools.

Responsibilities

• Process, validate, load, and curate clinical study datasets.
• Review study data for quality, completeness, consistency, and FDA/CDISC conformance.
• Apply CDISC standards, including SDTM and ADaM; SEND knowledge is preferred.
• Identify, investigate, and resolve data quality issues and validation errors.
• Apply FDA study-data guidance, business rules, and validation requirements.
• Support data-quality reporting, issue tracking, root-cause analysis, and remediation.
• Perform data review and validation using SQL, SAS, and/or other data management and validation tools.
• Support data operations and ensure accurate and timely processing of study data.
• Collaborate with clinical, data management, data quality, statistical, and technical teams.
• Provide functional expertise related to clinical and regulatory data management activities.

Skills

Analytical skills

Problem-solving

Communication

Collaboration

Education

Bachelor's or Master's degree in Life Sciences, Biostatistics, Computer Science, Health Informatics

Tools

SQL

SAS

Job description

CTIS is seeking a Clinical Data Specialist / Functional Business Analyst – Expert to support FDA CDER/OCS study data management and data quality activities. The ideal candidate will have hands-on experience with clinical study data processing, validation, loading, curation, and issue resolution, along with strong knowledge of FDA regulatory data requirements and CDISC standards.

Experience with SEND and nonclinical study data is highly preferred.