Role Overview – Philomath Research is hiring a QC Data Management System Specialist for a fully remote position based in Germany. This role is ideal for experienced data management professionals with expertise in quality control systems, clinical data management, validation processes, and regulatory compliance who can manage QC data systems, ensure data integrity, and support clinical research operations within a research-driven organization.

QC Data Management System Administration – You will administer and manage quality control data management systems by configuring system parameters, managing user access, ensuring system functionality, monitoring performance, and maintaining system documentation to support clinical trial data management and quality assurance processes.

Data Quality Control and Validation – You will perform data quality control and validation activities by reviewing clinical data entries, conducting data quality checks, identifying discrepancies and inconsistencies, implementing validation rules, and ensuring data accuracy, completeness, and compliance with study protocols and regulatory standards.

Database Design and Configuration – You will support database design and configuration by collaborating with clinical teams to define data requirements, creating data collection forms (eCRFs), configuring edit checks and validation logic, and ensuring databases are optimized for efficient data capture and reporting.

Quality Assurance and Compliance – You will ensure quality assurance and regulatory compliance by implementing Good Clinical Practice (GCP) standards, maintaining adherence to ICH guidelines, conducting system audits, managing documentation, and supporting inspections by regulatory authorities and sponsors.

Data Review and Query Management – You will conduct data review and manage query resolution processes by generating data quality reports, issuing data queries to clinical sites, tracking query resolution, and ensuring timely closure of discrepancies to maintain high-quality clinical trial data.

System Validation and Testing – You will support system validation and testing activities by developing test plans, conducting User Acceptance Testing (UAT), validating system upgrades, documenting test results, and ensuring all QC data management systems meet validation requirements and regulatory standards.

SOP Development and Documentation – You will develop and maintain Standard Operating Procedures (SOPs) and system documentation by creating user guides, validation documents, training materials, and system specifications, ensuring all documentation is current, comprehensive, and audit-ready.

Training and User Support – You will provide training and user support by conducting system training sessions for clinical teams and data entry personnel, troubleshooting system issues, responding to user queries, and ensuring all users are proficient in using QC data management systems.

How to Apply:

Send your updated CV to sagar.jha@philomathresearch.com. Please highlight your QC data management experience, your expertise with EDC systems (Medidata Rave, Oracle Clinical, etc.), your knowledge of GCP and regulatory compliance, and examples of data validation, system configuration, or quality assurance work you have performed in clinical research environments. Forward to anyone in your network who may be a strong fit.

About the Company:

Philomath Research is a research-driven organization committed to advancing clinical research excellence through high-quality data management, quality assurance, and regulatory compliance. The company is seeking an experienced QC Data Management System Specialist who brings deep expertise in clinical data systems, validation processes, and regulatory standards to support the integrity, quality, and compliance of clinical trial data within a fully remote and collaborative research environment.