Clinical Research Data Analyst - Hybrid/Remote

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The Office of the Vice Provost for Research & Scholarship, Clinical Research Management & Support Office (CRMSO) has an exciting job opportunity for a Clinical Research Data Analyst to work at the University of Miami.

CORE JOB SUMMARY

The Clinical Research Data Analyst performs advanced data analysis using various techniques. This role determines best practices and develops actionable insights and recommendations for the current business operations or issues. Key responsibilities include advanced business data interpretation, such as identifying trends or patterns of complex data sets, and designing of complex databases and dashboards data to optimize statistical efficiency and quality. This role also works collaboratively with internal and external clients and serves as a subject matter expert regarding compensation related concerns.

CORE JOB FUNCTIONS

• Designs and develops electronic Case Report Forms (eCRFs) for various clinical research studies, adhering to data management plans and customer specifications.
• Validates programming code and ensure accurate logic checking, data validation, and edit checks to maintain data integrity and compliance with regulatory requirements.
• Builds and maintains data entry screens, custom reports, and data integrations as required by study protocols and project objectives.
• Builds and maintains forms library, variable naming conventions, and adhere to standard formatting.
• Collaborates with internal partners to create, implement, and enhance data management plans, ensuring efficient data collection, management, and preparation for analysis.
• Provides technical expertise in basic integrations, utilizing scripting languages like R and JavaScript to facilitate data exchange between different systems and platforms.
• Supports the team during user acceptance testing (UAT) of eCRFs, troubleshooting issues, and implementing necessary adjustments.
• Maintains knowledge of the latest developments in data management, clinical trial processes, and relevant technologies and apply them to improve workflows and data quality.
• Works closely with cross-functional teams, including biostatisticians, clinical operations, and regulatory affairs, to ensure deliverables are of the highest quality, delivered on time, and within budget constraints.
• Collaborates with external vendors and partners to ensure smooth implementation of SaaS platforms and other technology solutions.

This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.

CORE QUALIFICATIONS

Education:

Bachelor’s degree in a related field (e.g., computer Science, Life Sciences, or Engineering).

Experience:

• Minimum 5 years proven experience working in a similar role within the clinical research industry, with a strong understanding of clinical trial processes and data management. Any appropriate combination of relevant education and/or work experience may be considered.
• Proficiency in designing and programming eCRFs, utilizing tools like RAVE, Medidata, or other industry-standard eCRF platforms.
• Strong programming skills in R and JavaScript to handle data transformations, integrations, and customization of data collection interfaces.
• Familiarity with data management plans and customer specifications for eCRFs, edit checks, data integrations, and custom reports.
• Knowledge of SaaS platforms and their implementation for data collection and management in clinical trials.

Knowledge, Skills and Attitudes:

• Experience with R programming and packages commonly used in clinical data analysis.
• Familiarity with database systems and SQL for data manipulation and querying.
• Knowledge of clinical trial regulations and guidelines (e.g., ICH-GCP) related to data management.
• Previous experience working with EDC (Electronic Data Capture) systems.

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