We are seeking a Principal Clinical Programmer (Rave/Veeva) to be a subject matter expert and lead developer for our core business packages. This pivotal role involves providing technical support, leading programming projects, and mentoring a team to accelerate the delivery of clinical therapies.
Roles and Responsibilities
- Act as a subject matter expert and provide technical support for core business packages such as Medidata, Rave, Oracle OC/RDC, and Veeva.
- Design, write, validate, and maintain software to meet project specifications in a timely and productive manner.
- Generate and maintain all required documentation, including specifications and validation efforts for eCRFs, database creation, edit checks, and more.
- Proactively monitor applications for workflow alerts, system errors, and troubleshoot programming defects.
- Lead development activities for clinical programming projects, using an analytical approach to problem-solving.
- Ensure high-quality deliverables by providing senior review of program-level and multi-study core deliveries.
- Assist with the creation and execution of change orders.
- Provide leadership, mentorship, training, and guidance to other department members.
- Oversee and manage multiple concurrent studies, and proactively alert management of delivery and resourcing needs.
- Assist with the management of application vendors, including monitoring service level agreements (SLAs).
- Possess and maintain broad knowledge in the field of clinical programming and clinical data management.
- Advise on administrative policies and procedures, technical problems, and priorities.
Skills Required
- Bachelor's degree; Master's degree preferred.
- Proven experience in End-to-End clinical programming in Rave OR Veeva.
- Hands-on experience with EDC build, Study/DB Build, eCRF Build, Edit Checks programming, Migrations & PPC.
- Strong Custom Functions programming experience with Rave EDC.
- Must have lead experience.
- The ability to deal effectively with sponsors and internal customers at all levels.
- Excellent written and verbal communication and interpersonal skills.
- Demonstrated experience in managing multiple priorities in a dynamic environment.
- Proficiency in Microsoft Office Suite.
- Experience with programming languages such as PL/SQL, SAS, C#, or VB is preferred.
- Ability to travel as necessary.