Clinical Study Builder

More specifically, the Clinical Study Builder must:

• Develops programming/configuration of Veeva and Medrio CRFs, folders, edit checks, derivations, integrations, migrations, and reports, based on protocol requirements.
• Sets up Coder, Local Lab, Targeted SDV modules.
• Leads eCRF design and review meetings.
• Provides user support and technical support.
• Conducts end user training.
• Works collaboratively with Lead Data Managers.
• Works effectively with vendor partners in testing and deployment.
• Troubleshoots and resolves technical issues in a timely manner.
• Participates in the definition, writing and updating of Veeva CDMS SOPs

Experience

• Minimum of 2 years of Veeva CDMS study build experience;

Knowledge and skills

• Certified Veeva Study Builders preferred.
• Medidata Rave build experience preferred.
• Detailed knowledge and experience in case report form design, programming databases;
• Must be able to lead multiple study builds or post-release changes at the same time;
• Understanding of the drug development process and of applicable regulations, including Good Clinical Practices, ICH Guidelines;
• Highly organized and detail-oriented with effective project planning and time management skills.
• Strong verbal and written communication skills in English;
• Ability to work in a fast-paced environment with demonstrated agility to juggle and prioritize multiple competing demands.