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Senior, niche clinical-data role with regulatory requirements and remote work reduces applicant density.
Requires deep clinical trial and regulatory expertise, limiting cross-industry transferability.
Mandatory 12 years experience plus clinical trial, regulatory, and tool requirements make filters highly rigid.
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Lead and coordinate end-to-end clinical data collection and cleaning activities ensuring data quality aligns with contract and sponsor expectations.
Act as primary liaison between Clinical Data Science and other functions including Project Management and Clinical Monitoring to drive clinical data quality and project progress.
Develop clinical data acquisition plans and analytical tools to identify and resolve data issues impacting trial validity, while managing timelines and resource planning.
Minimum 12 years of experience in Data Management/Data Science including 4 years in project management.
Bachelor’s degree in biological sciences, computer sciences, mathematics, data sciences or related natural science/healthcare fields; MS preferred; equivalent experience considered.
Experience with Clinical Data Science practices, relational database systems, protocol interpretation, and data cleaning/specification development.
Knowledge of drug development processes, ALCOA++ data quality principles, ICH/GCP regulatory requirements, and proficiency in data analysis tools like Python, R, SAS, and data visualization tools.
Experienced leader capable of managing cross-functional teams and coordinating complex clinical data projects in line with contract and sponsor requirements.
Strong project management skills with ability to navigate clinical data quality risks and align data flow with study protocols and regulatory standards.
Technical proficiency in advanced analytics (AI/ML preferred), clinical data systems, and regulatory compliance to ensure reliable clinical trial data deliverables.