Clinical Data Specialist

Omega Hires; Rockville (MD); On-site; USD 90,000 - 130,000; Full time

Job summary

Omega Hires seeks a Specialist / Functional Business Analyst – Expert to support FDA CDER/OCS study data management and data quality activities, including CDISC SDTM/ADaM application and SEND knowledge.

Candidate will validate, load, curate datasets and collaborate with clinical, data management, and regulatory teams to ensure compliant, timely study data processing.

Qualifications

• Bachelor’s or Master’s degree in Life Sciences or related field.
• Hands-on clinical study data management experience.
• Strong knowledge of CDISC standards (SDTM/ADaM).
• Experience with data validation and data quality review.
• Proficiency in SQL, SAS or similar tools.
• Strong analytical and collaborative skills.

Responsibilities

• Process, validate, load, and curate clinical study datasets.
• Review study data for quality, completeness, consistency, and CDISC conformance.
• Apply CDISC standards, including SDTM and ADaM; SEND knowledge 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, and remediation.
• Use SQL, SAS, or other tools for data review and validation.
• Collaborate with clinical, data management, and technical teams.
• Provide functional expertise in clinical and regulatory data management.

Skills

Clinical data mgmt

CDISC standards

SDTM/ADaM

SQL

SAS

Data validation

Regulatory data

Data curation

Education

Bachelor’s or Master’s degree in Life Sciences

Tools

SQL

SAS

Job description

Position Overview

The 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.

Key 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.

Required Qualifications

• - Bachelor's or Master's degree in Life Sciences, Biostatistics, Computer Science, Health Informatics, or a related field.
• - Hands‑on experience in clinical study data management, data operations, or regulatory data.
• - Strong knowledge of CDISC standards, including SDTM and ADaM.
• - Experience with data validation, curation, quality review, and issue resolution.
• - Experience with SQL, SAS, or similar data analysis and validation tools.
• - Strong analytical, problem‑solving, communication, and collaboration skills.

Preferred Qualifications

• - Experience supporting FDA CDER/OCS programs.
• - Experience with SEND and nonclinical study data.
• - Current or recent FDA access/credentials.
• - Ability to begin onboarding promptly upon contract award.
• - Recent U.S. residency history, preferably having lived in the United States for at least 3 of the past 5 years.
• - Knowledge of FDA study‑data guidance and validation requirements.
• - Functional/business analysis experience within clinical, regulatory, or life sciences data environments.
• - Experience working with data management and data quality teams.- Familiarity with FDA data standards, regulatory submissions, and clinical study datasets.

Open to Travel (within United States)

* Yes