Clinical Data Management

Position Summary

The Clinical Data Manager manages end-to-end data management activities for clinical trials. You will design data collection tools, write data management plans, clean data, and lock databases in compliance with industry standards.


Key Responsibilities

• Database Setup: Design and test Electronic Data Capture (EDC) systems, Case Report Forms (CRFs), and validation logic checks.

• Data Cleaning & Queries: Monitor real-time data, identify discrepancies, and issue data queries to resolve missing or inconsistent information. 

• Management Plans: Develop project-specific Data Management Plans (DMPs) detailing coding methodologies, data transfer protocols, and timelines.

• External Data Integration: Reconcile data streams from external vendors, such as central labs, imaging, and eCOA. 

• Database Lock: Oversee data finalization, medical coding (e.g., MedDRA), and database lock activities for statistical analysis.

• Compliance & Audits: Ensure alignment with FDA regulations, 21 CFR Part 11, ICH/GCP guidelines, and CDISC standards.

Qualifications & Skills

• Education: Bachelor’s degree in Life Sciences, Health Informatics, Statistics, Computer Science, or a related field.

• Experience: 3+ years of direct clinical data management experience in pharmaceutical, biotech, or CRO settings.

• Technical Skills: Proficiency with EDC systems (e.g., Rave, Veeva) and data analysis tools like SAS, SQL, or R.

• Knowledge Base: Strong understanding of Good Clinical Practices (GCP) and CDISC standards (SDTM/CDASH).

• Soft Skills: Exceptional attention to detail, project management capabilities, and cross-functional communication skills