Description

JOB SUMMARY

Serves as lead Clinical Programmer to manage and support all functional tasks and project deliverables from single study assignments to large programs of studies. Manages multiple project timelines and deliverable whilst leading less experienced programmers. Designs, writes,validates, and maintains software to meet specifications. Specifies, develops, and validates applications supporting data capture and processing. As senior technical subject matter expert, supports clinical programming and Data Management staff for Electronic Data Capture (EDC), reporting, and processing tools. Proactively monitors internally and externally hosted applications for performance and/or system errors. Supports projects and applications externally. Manages external application vendor issues, integrations, and implementations. May have supervisory responsibility and/or oversight for a team of lead clinical programmers

within a program.

Job Responsibilities

 Provides application administration and technical support as the subject matter expert on all core business packages, including but not limited to: Medidata, Rave, Oracle OC/RDC, Oracle Inform, SAS, and supplemental packages such as migration mentoring/review, reporting tools, custom functions, etc. Utilizes primary development tools and other supporting tools to design, write, validate, and maintain software to meet specifications in a

timely and productive manner following standard development procedures.

 Generates and maintains all required documentation including the development of specifications, coding, and validation efforts in support of annotated Case Report Forms (CRF)s, database creation, coding setup, edit check procedures, import setup and processing, export setup and processing, listings, and custom reports

 Monitors applications proactively for workflow alerts, system errors, performance issues and troubleshoot programming deliverable defects.

 Performs system integrations activities, application updates, and user acceptance testing.

 Serves on project teams to coordinate and lead development activities for clinical programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive feedback. Keeps those responsible for project management informed of any issues that might impact project target dates, scope, or budget and escalates potential problems effectively and in a

timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources.

 Participates in and provides input at project review and departmental review meetings. Participates in bid defenses.

 Ensures high quality deliverables by providing senior review of ’program level’/multi-study core deliveries for accuracy. Attends sponsor audits and assists with in-progress audits.

 Reviews and provides input on study budgets, manages project level metrics, progress, and status, for large programs of studies from key sponsors. Monitors scope of work to actual work, alerting management of potential change orders; manages and executes the change order to completion. Assists with the creation of change orders.