Bachelor's or master's degree in science or healthcare-related field, or equivalent practical experience
2+ years of experience in clinical data management, clinical or lab research, or related work in the medical device or pharmaceutical industry
Advanced degree in biomedical science, informatics, biostatistics, or relevant experience
Familiarity with pharmaceutical industry health data standards such as CDISC and MedDRA
Strong project management and analytical skills
Experience navigating clinical databases like EDCs and EMRs
Knowledge of clinical trial processes and regulatory requirements such as ICH GCP and HIPAA
Responsibilities
Develop real-world data variables from various data sources, ensuring comprehensive data capture and abstraction guidance
Lead feasibility testing to optimize data capture strategies and implement validation checks for data integrity
Collaborate with team members to enhance data models and improve processes
Manage a portfolio of real-world data deliverables, maintaining clinical data expertise
Oversee real-world data management throughout product lifecycle, including quality check logic and efficiency analysis
Identify product enhancement opportunities through feedback and trends analysis
Ensure documentation meets audit-readiness standards and adherence to data protocols
Benefits
Collaborative work environment encouraging innovative problem-solving
Opportunities for professional development and continuous learning
Exposure to cutting-edge clinical data methodologies
Engagement with industry trends and the clinical landscape
Supportive team culture focused on quality and efficiency
Full Job Description
Responsibilities:
Reporting to the Clinical Data Manager, you'll be responsible for the development of real-world data variables from structured and unstructured data sources, including designing data capture forms and supplemental procedures to instruct the abstraction process
You'll lead the execution of feasibility testing to de-risk data capture approaches, and own the implementation of data validation checks to ensure data quality
In addition, you'll 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
Plan and execute feasibility experiments for variable development, applying insights to align and recommend optimal variable design, data source(s), efficiency, quality, and production cost
Contribute to the development and maintenance of internal and external real-world data variable user guidance
Identify opportunities for improvement in processes/workflows, contribute to problem-solving discussions with stakeholders, and support the design and implementation of solutions, including but not limited to tooling, templates, or modifications to software platforms
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
In addition, you have 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
You have an advanced degree in biomedical science, informatics, biostatistics, or relevant experience
ware 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
Experience managing data for real-world evidence programs, registries, or other post-marketing studies
