Clinical Data Manager

Katalyst CRO; Austin (TX); On-site; USD 68,500 - 217,100; Full time

Job summary

A leading clinical research organization in Austin is seeking a Clinical Data Manager to oversee the integrity and quality of clinical trial data. The ideal candidate will have a Bachelor's degree and at least 3 years of experience in clinical data management, with proficiency in EDC platforms. The role involves collaboration with cross-functional teams to ensure regulatory compliance and data standards. Competitive salary and contract employment offered.

Qualifications

• Minimum of 3 years of experience in clinical data management within a pharmaceutical, biotech, or CRO environment.
• Proficiency in EDC platforms.
• Strong understanding of ICH-GCP and FDA regulations.

Responsibilities

• Oversee and ensure the integrity and quality of clinical trial data.
• Collaborate to support study execution.
• Manage database lock activities and contribute to clinical study reports.

Skills

Communication skills

Analytical skills

Organizational skills

Problem-solving skills

Education

Bachelor's degree in Life Sciences, Computer Science, Health Informatics, or related field

Tools

Medidata Rave

Oracle InForm

Veeva

REDCap

Job description

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Location: Austin, TX

Salary: $68,500.00 - $217,100.00

Seniority level: Associate

Employment type: Contract

Job function: Information Technology

Industries: Pharmaceutical Manufacturing

Responsibilities

• 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.

Requirements

• 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.