Clinical Data Specialist

Responsibilities

• Develop real-world data variables from structured and unstructured data sources, including designing data capture forms and supplemental procedures to instruct the abstraction process.
• Lead the execution of feasibility testing to de-risk data capture approaches, and own the implementation of data validation checks to ensure data quality.
• Work alongside other team members on ways to improve data models.
• Manage, maintain, and serve as clinical data expert for a portfolio of real-world data deliverables.
• Plan and execute real-world data management activities through the lifecycle of a product, including data model development, data processing methods (e.g., abstraction, structured, machine learning, etc.), design of data capture forms and associated instructions, creation of quality check logic, analysis of controls for efficiency and effectiveness, and development of quality check resolution guidance.
• Surface opportunities for product enhancements by leveraging feedback channels, including but not limited to client requests, clinical landscape developments, industry trends, regulations, and/or data processing challenges.
• Contribute to the development and maintenance of internal and external real-world data variable user guidance.
• Maintain audit-readiness of documentation through conformance to procedures and applicable data standards.

Requirements

• Bachelor's or Master's degree in science or healthcare related field, or equivalent practical experience.
• 2+ years of experience working in clinical data management, clinical or lab research, and/or related work experience in a medical device or pharmaceutical industry/company.
• An advanced degree in biomedical science, informatics, biostatistics, or relevant experience.
• Aware of pharmaceutical industry health data standards such as CDISC and MedDRA.
• Passionate and collaborative problem-solver who values the opportunity to think beyond the way things are.
• Experience navigating clinical databases such as EDCs, EMRs, or other data management systems.
• Familiar with clinical research and medical product development, clinical trial processes and related regulatory requirements or information governance frameworks (e.g ICH GCP, Good Clinical Data Management Practices, 21CFR11, HIPAA).
• Strong project management, organizational, analytical, and written and verbal communication skills.
• Self-motivator who is able to identify problems and propose solutions in a highly dynamic and fast-paced environment.