Clinical Data Manager

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Location:

Austin, TX

Salary: $68,500.00 - $

Seniority level:
Associate

Employment type:

Contract

Job function:
Information Technology

Industries:
Pharmaceutical Manufacturing

• Oversee, maintain, and ensure the integrity and quality of clinical trial data from collection through database lock.
• Ensure data accuracy, consistency, and compliance with regulatory and protocol-specific requirements.
• Collaborate with Clinical Operations, Biostatistics, Medical Writing, and Regulatory Affairs to support timely and compliant study execution.
• Design and review Case Report Forms (CRFs) and Electronic Data Capture (EDC) systems to ensure accurate and complete data capture aligned with the study protocol.
• Develop and maintain data management plans (DMPs), data validation specifications, and CRF completion guidelines.
• Oversee data cleaning activities, generate, review, and resolve data queries in collaboration with clinical sites and study teams.
• Perform ongoing data reviews to identify trends, inconsistencies, or protocol deviations.
• Ensure adherence to data standards (e.g., CDISC, SDTM) and regulatory requirements (e.g., FDA, ICH-GCP).
• Manage database lock activities and contribute to preparation of clinical study reports (CSRs).
• Serve as primary point of contact for data management vendors and oversee their deliverables.
• Participate in study team meetings and provide status updates related to data quality and timelines.
• Support audit readiness and participate in regulatory inspections when required.

• Bachelor's degree in Life Sciences, Computer Science, Health Informatics, or related field.
• Minimum of 35 years of experience in clinical data management within a pharmaceutical, biotech, or CRO environment.
• Proficiency in EDC platforms (e.g., Medidata Rave, Oracle InForm, Veeva, REDCap).
• Strong understanding of ICH-GCP, FDA regulations, and CDISC standards.
• Experience with data listings, query management, edit check programming, and coding dictionaries (e.g., MedDRA, WHODrug).
• Excellent organizational, analytical, and problem‑solving skills.
• Strong communication and collaboration skills across cross‑functional teams.