Senior Clinical Programmer (Rave)

Overview

Senior Clinical Programmer working primarily in Rave to design, build, validate and maintain clinical programming deliverables, leading programming activities across multiple concurrent studies.

What you'll do

• Use primary development tools including Medidata, Rave, Oracle OC/RDC, Oracle Inform, and/or SAS, and other supporting tools to design, write, validate, and maintain software to meet specifications following standard development procedures.
• Generate and maintain all required documentation, including specifications, programs, and validation efforts for annotated CRFs, database creation, coding configuration, edit check procedures, import and export setup and processing, listings, and custom reports.
• Serve on project teams to coordinate and lead clinical programming development activities.
• Keep project management informed of issues impacting target dates, scope, or budget, and escalate potential problems in a timely manner.
• Provide technology support to clinical programming staff, Project Analysts, Data Managers and others.
• Provide application administration and technical support as subject matter expert on core business packages, including Oracle Inform, MDSOL Rave, Oracle RDC, SAS, and supplemental packages such as migration mentor/review, reporting tools, and custom functions.
• Ensure high quality deliverables through senior review of study-level, program-level and multi-study core deliveries for accuracy.
• Attend sponsor audits and assist with in-progress audits.
• Review and provide input on study budgets, monitor scope of work against actual work, alert management to potential change orders, and manage and execute change orders to completion.
• Monitor applications for workflow alerts, system errors and performance issues, and provide second tier help desk support as needed.
• Perform system integration activities, application updates and user acceptance testing.
• Provide leadership, training, guidance and support to other department members based on expertise.
• Collaborate with clients, peers, lead programmers, project teams and requestors to clarify and finalize specifications.
• Attend Quick Start Camps (QSCs) as the lead Clinical Programmer for assigned studies.
• Lead clinical programming activities on three (3) to ten (10) concurrent studies depending on scope, similarity, program and resourcing requirements.
• Manage project resources and proactively alert management to delivery and resourcing needs.

What you'll need

• Bachelor's degree preferred, or equivalent combination of related education and experience.
• 5 - 8 years of experience in clinical programming.
• End-to-end clinical programming experience in Rave.
• Experience in study/DB build, eCRF build, edit checks programming, migrations and custom functions.
• Study leading experience, including amendments and publishing checks and migrations.
• At least 2+ years of custom function experience.
• Ability to deal effectively with sponsors and internal customers at all levels.
• Excellent written and spoken communication and interpersonal skills, with an ability to inform.
• Demonstrated experience managing multiple priorities in a highly dynamic environment.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), email and voicemail.
• Ability to travel as necessary (up to 25%).

Nice to have

• Protocol interpretation.
• Experience working in a matrix-structured environment.
• Experience with programming languages such as PL/SQL, SAS, C#, or VB.

Details

• Location: Hyderabad, India.
• Work mode: Hybrid.
• Travel: up to 25% as necessary.