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 Associate Director (Clinical Trial Reporting)
Builds
Data listings, visualizations, and data review artifacts for clinical trials.
Domain
Pharmaceutical clinical development and regulatory compliance
Required skills
Clinical trial reporting, regulatory compliance (FDA/ICH), vendor management, team leadership, process optimization, data quality checks, TMF management
Preferred skills
Programming team leadership, strategic vendor partnerships, technology strategy enablement
Technologies
Veeva CDB, Elluminate, JReview, Metadata Rave, CQL, SQL, SAS, R, Python, RShiny, CluePoint
Responsibilities
Develop listings and visualization specifications; maintain and test programming tasks; oversee Functional Service Provider (FSP) resource allocation; mentor staff; ensure compliance with GxP and trial master file requirements; represent function during audits and regulatory inspections.
Seniority
Senior, hands-on IC with line management