Clinical Data Specialist
Clinical Data Specialist
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Job Description
In this role you will work with the Clinical Data team to interpret and organize clinical oncology data. Reporting to the Clinical Data Manager you will develop realworld data variables from structured and unstructured sources design data capture forms and establish procedures for data abstraction. You will lead feasibility testing to refine data capture methods and implement data validation checks to ensure quality. Collaboration with team members on data model improvements will be a key aspect of the role.
Key Responsibilities:
Serve as a clinical data expert for a portfolio of realworld data deliverables.
Manage and execute data management activities throughout a products lifecycle including data model development data processing (e.g. abstraction machine learning) design of data capture forms quality check logic and guidance for quality check resolution.
Identify opportunities for product enhancements based on client feedback industry trends regulatory changes and data challenges.
Plan and conduct feasibility experiments for variable development recommending optimal design data sources and production efficiencies.
Develop and maintain internal and external guidance for realworld data variables.
Improve workflows by identifying process enhancements collaborating with stakeholders and implementing solutions (e.g. tooling templates).
Ensure documentation auditreadiness in line with procedures and applicable data standards.
Requirements:
2 years in clinical data management clinical or lab research or similar experience in the medical device or pharmaceutical industry.
Experience with clinical databases (EDCs EMRs etc.) knowledge of health data standards (CDISC MedDRA) and familiarity with SQL SAS R Python or data analysis platforms (PowerBI SPSS Tableau).
Understanding of clinical research clinical trials and regulatory requirements (ICH GCP 21CFR11 HIPAA).
Strong project management organizational analytical and communication skills; ability to work in a fastpaced dynamic environment.
Bachelor s or Master s degree in a science or healthcarerelated field or equivalent experience.
Foundational knowledge of statistics and experimental design.
Extra Qualifications:
Familiarity with cancer treatment and terminology.
Experience managing data for realworld evidence programs or registries.
Knowledge of machine learning model development.
Advanced degree in biomedical science informatics or biostatistics.
Work Arrangement:
This hybrid role combines remote work with three office days per week as agreed upon with the team.
Employment Type
Full Time
