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Job Description
Structured overview of role & requirementsAbout This Role
Develop and configure data surveillance systems and Key Risk Indicators (KRIs) to ensure clinical trial data quality and integrity.
Analyze clinical and operational data against project-specific Quality Tolerance Limits, document findings, and escalate issues as necessary.
Collaborate with cross-functional global teams to support regulatory compliance, central monitoring, and clinical study operations from planning through closeout.
Minimum Requirements
Bachelor's degree in medical, biological science, pharmacy, data analytics, or relevant clinical/technology/business field.
At least 2 years of relevant medical, clinical, or data management work experience.
Knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial processes.
Basic SAS programming and/or SQL scripting skills.
Ideal Candidate Profile
Experienced in Risk-Based Quality Management (RBQM) and data surveillance methodologies within clinical research or regulated healthcare environments.
Capable of working effectively in matrix and global virtual teams with strong communication and stakeholder engagement skills.
Proficient in using clinical trial management systems (CTMS), electronic data management systems (EDMS), and relevant data surveillance technologies.