Clinical Study Builder-Philippines

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 Rave CDMS, but might also be requested to build CRF using different EDC systems, like Medrio or Veeva.

In addition, this position is required to conduct all these activities in conformance with applicable regulatory requirements, industry guidelines, and Indero standard operating procedures (SOPs) while respecting Indero’s commitment to sponsor’s requirements and timelines

More specifically, the Clinical Study Builder must:

• Develops programming/configuration of Rave, 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 Rave CDMS SOPs

Education

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



Experience

• Minimum of 2-4 years of Rave CDMS study build experience;

Knowledge and skills

• Certified Rave 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.