Responsible for the design, development, testing, implementation, maintenance and support of clinical databases and applications.
Interface directly with internal teams (Data Management, Project Management, etc.), EDC vendor, clients and third-party vendors to gather requirements and provide status updates.
Provide operational and technical training to end users and junior staff.
Play a lead role in internal software projects that require specialized programming and/or scripting when required.
Support EDC integrations and customizations (e.g., Rave API, Advanced Custom Function programming).
Collaborate with cross-functional teams to deliver database solutions and ensure data management best practices.
Requirements
Must have experience in developing and customizing clinical data management databases in a clinical, scientific or health care discipline
Bachelor’s and/or a combination of related experience
Rave API integration experience using external vendor modules
Rave Advanced Custom Function programming experience
Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook.
Able to handle a variety of clinical research tasks.
Excellent organizational and communication skills
Professional use of the English language; both written and oral.
Experience in Object Oriented Programming (C#, C++, VBS, etc.…), scripting language (PERL, etc.), SAS, R, SQL
Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.)
Experience in clinical database management system development.
Experience in a clinical, scientific or healthcare discipline.
Experience in utilizing various clinical database management systems
Broad knowledge of drug, device and/or biologic development and effective data management practices
Strong leadership and interpersonal skills
Must be able to communicate effectively in the English language.
Oncology and/or Orphan Drug therapeutic experience (preferred)
Base SAS®, SAS/STAT and SAS/ACCESS software (preferred)
SAS Macro programming language (preferred)
Advanced experience in Database Management, object-oriented programming (preferred)