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EDC Clinical Study Builder


The EDC Study Builder, will works 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. Candidates will be working in a dynamic and collaborative environment. In addition, solution creation includes custom function implementation and testing, and system integrations using Rave Web Services and the Batch Uploader. The Medidata Programmer – Study Builder might also be requested to build CRF using different EDC systems, like Medrio.

 

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.

 

RESPONSABILITIES

 

More specifically, the EDC Study Builder must:

 

  • Develops programming/configuration of Rave and Medrio CRFs, folders, edit checks, derivations, integrations, migrations, and reports, based on protocol requirements.
  • Understands and analyzes Rave Custom Functions. For designated personnel, able to write and debug Rave CFs.
  • Set up Coder, Lab, IRT, Targeted SDV modules.
  • Lead eCRF design and review meetings.
  • Administers Rave modules including Reports Administration, PDF Services, Batch Uploader, User Administration, and Site Administration.
  • 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 Medidata Rave SOPs.

PROFILE

 

Education

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

 

Experience

  • Minimum of 5 years of Medidata Rave study build experience;

 

Knowledge and skills

  • Certified Medidata Rave Study Builders preferred.
  • Detailed knowledge and experience in case report form design, central laboratories, programming databases, query resolution, data validation
  • Must be able to lead multiple studies 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 

 

The work environment 

At Innovaderm, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. 

 

In this position, you will be eligible for the following perks: 

  • Flexible work schedule 
  • Permanent full-time position 
  • Ongoing learning and development 

 

About Innovaderm 

Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Innovaderm continues to grow and expand in North America and Europe. 

 

Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. As such, Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. 

Innovaderm only accepts applicants who can legally work in India.

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