Senior Manager - Clinical Programming
CurrentProvides leadership and content expertise for programming activities from start-up through statistical analysis stage of clinical studies to effectively manage data capture, review, and database lock activitiesProvide strategic input into the analysis of new systems and software to support clinical trials data collection, quality, and integrityLead the implementation of programming standards and conventionsResponsible for leading internal and outsourced Clinical Programming activities in support of Clinical Research studies and managing the design, development, validation and implementationOversee ongoing support to electronic case report form (eCRF) systems, external data acquisitions, reporting/business intelligence tools (e.g. SpotFire, J-Review), and other programs (e.g. SQL, PL-SQL, SAS).Responsible the implementation of quality, efficient, and consistent approaches to carrying out Clinical Programming tasks.Responsible for participating in the vendor selection process and managing vendors (e.g. CROs, FSPs, Technology Providers, etc.) in accordance with applicable processes and procedures.Involvement in assessment/re-assessment of vendor capabilities, as necessaryDrive and contribute to continuous improvement.Delivering training to Clinical Programming and other functions/departments as necessary.Monitors compliance to controlled procedural documents (e.g. SOPs) and proactively addresses gaps in processes or understanding of processes by Clinical Programming staff.Contribute to department and other project budget planning
