Clinical Data Specialist

Clinical Data ManagerResponsibilities: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 processYou'll lead the execution of feasibility testing to de-risk data capture approaches, and own the implementation of data validation checks to ensure data qualityIn addition, you'll work alongside other team members on ways to improve data modelsManage, maintain, and serve as clinical data expert for a portfolio of real-world data deliverablesPlan 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 guidanceSurface 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 challengesPlan and execute feasibility experiments for variable development, applying insights to align and recommend optimal variable design, data source(s), efficiency, quality, and production costContribute to the development and maintenance of internal and external real-world data variable user guidanceIdentify 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 platformsMaintain 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 experienceIn 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/companyYou have an advanced degree in biomedical science, informatics, biostatistics, or relevant experienceAware of pharmaceutical industry health data standards such as CDISC and MedDRAPassionate and collaborative problem-solver who values the opportunity to think beyond the way things areExperience navigating clinical databases such as EDCs, EMRs, or other data management systemsFamiliar 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 skillsSelf-motivator who is able to identify problems and propose solutions in a highly dynamic and fast-paced environmentExperience managing data for real-world evidence programs, registries, or other post-marketing studies