Clinical Study Builder / Concepteur d'Études Cliniques

at  Innovaderm Research

The Clinical Study Builder will work closely with data management and statistical staff to design and develop electronic case report forms (eCRFs), visit schedules and associated data quality checks for medical research studies. This position is required to work in a dynamic and collaborative environment. In addition, solution creation includes implementation , testing, and system integrations. The Clinical Study Builder will work principally on Veeva CDMS, but might also be requested to build CRF using different EDC systems, like Medrio or Rave.
In addition, this position is required to conduct all these activities in conformance with applicable regulatory requirements, industry guidelines, and Innovaderm standard operating procedures (SOPs) while respecting Innovaderm’s commitment to sponsor’s requirements and timelines

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

Requirements:

EDUCATION

• B.Sc. or M.Sc, or in a related field of study;
  

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.
  Our company:

Please refer the Job description for details