Senior clinical programmer (Rave)

Overview

Senior clinical programmer role focused on Rave, providing application administration, technical support and leadership on clinical programming projects.

What you'll do

• Provide application administration and technical support as the subject matter expert on core business packages, including Medidata, Rave, Oracle OC/RDC, Oracle Inform, SAS, and supplemental packages such as migration mentoring/review, reporting tools and custom functions.
• Use primary development tools and supporting tools to design, write, validate and maintain software to meet specifications in a timely and productive manner following standard development procedures.
• Generate and maintain required documentation, including specifications, coding and validation efforts for annotated Case Report Forms (CRFs), database creation, coding setup, edit check procedures, import and export setup and processing, listings and custom reports.
• Monitor applications proactively for workflow alerts, system errors and performance issues, and troubleshoot programming deliverable defects.
• Perform system integration activities, application updates and user acceptance testing.
• Serve on project teams to coordinate and lead development activities for clinical programming projects.
• Keep those responsible for project management informed of issues that might impact project target dates, scope or budget, and escalate potential problems effectively and in a timely manner.
• Balance multiple task assignments and communicate needs to supervisor to obtain needed resources.
• Provide senior review of 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, and manage project-level metrics, progress and status for large programs of studies from key sponsors.
• Monitor scope of work against actual work, alert management to potential change orders, and manage and execute change orders to completion; assist with creating change orders.
• Provide leadership, mentorship, training, guidance and support to other department members based on expertise in specific skill sets.
• Collaborate with clients, peers, lead programmers, project teams and/or requestors to clarify and finalize specifications.
• Attend Quick Start Camps (QSCs) in the lead Clinical Programmer role for assigned studies.
• Provide leadership and oversight of five (5) to twenty (20) concurrent studies depending on scope, similarity, program and resourcing requirements, including oversight of other lead programmers and their studies.
• Manage project resources and proactively alert management of delivery and resourcing needs.
• Assist with management of application vendors and serve as initial escalation contact; monitor vendor service level agreements (SLAs) and report metrics to upper management.
• Supervise implementations of upgrades and new modules of remotely hosted vendors, acquiring and storing all documentation.
• Maintain broad knowledge of clinical programming and clinical data management through reading, self-training, training classes and professional meetings.
• Contribute to updates of standard operating procedures and work instructions in line with department and company process and policy.
• As required, supervise a team of clinical programmers, including performance appraisals, employee advising, assigning project work, reviewing workload and setting development goals.
• Resolve conflicts and priorities at the program level before making recommendations to management, and advise on administrative policies, procedures, technical problems, priorities and methods.

What you'll need

• Experience in Rave programming and custom functions programming (moderate to complex), with minimum 2+ years in custom functions (CF).
• Overall 5-7+ years of experience is required.
• Migration exposure.
• Experience with Publish Check, PPC, TSDV and study build programming.
• SDBE Rave certification (mandatory).

Nice to have

• Veeva CDMS experience.

Details

• Location: IND-Remote.