Katalyst CRO ยท 1 month ago
Clinical Data Specialist
Austin, TX
Contract
Onsite
Entry, Mid Level
2+ years expKatalyst CRO is a company focused on clinical research, and they are seeking a Clinical Data Specialist to manage and enhance real-world data deliverables. The role involves developing data variables, executing feasibility testing, and ensuring data quality throughout the lifecycle of a product.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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
Qualification
Required
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
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
Experience managing data for real-world evidence programs, registries, or other post-marketing studies
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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