Clinical Data Specialist

Clinical Data Specialist

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- Bachelors or Masters 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.