Associate Director, Clinical Trial Reporting
Core
Lead clinical trial reporting activities to deliver data listings and visualizations for regulatory submissions and statistical analysis.
Role type
Senior IC clinical trial reporting director
Builds
Data listings, visualizations, and data review libraries for global development programs
Domain
Pharmaceutical clinical development and regulatory reporting
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
Clinical trial reporting expertise, project management, team leadership, vendor management, regulatory compliance (FDA/ICH), data quality checks, process optimization, talent development
Preferred skills
Programming team leadership, strategic vendor partnerships, cross-functional influence
Technologies
Veeva CDB, Elluminate, JReview, Metadata Rave, CQL, SQL, SAS, R, Python, RShiny, CluePoint
Responsibilities
Drive strategy with preferred vendors for regulatory compliance, partner with data configuration and standards teams on data cleaning and visualizations, organize reporting activities for assigned studies, oversee functional service provider resource allocation, establish partnerships within clinical data operations, review and optimize reporting processes, train and mentor staff, represent function during internal audits and regulatory inspections
Seniority
Senior, hands-on IC with leadership responsibilities
