EDC Study Builder 1

EDC Study Builder – Level 1

The EDC Study Builder – Level 1 creates and maintains the study-defined data collection screens for EDC systems in conjunction with the Database Administrator, SDTM Specialist and Protocol and Laboratory Data Managers. This includes designing and building the study in an EDC system, including forms design, importing existing forms, creating study matrices, creating data dictionaries, preparing eCRF migrations, drafting validation materials, creating print matrices and publishing the eCRF completion guide.

Major duties and responsibilities:

• Working closely with Protocol Data Managers and SDTM Specialists as a member of study build teams to create eCRFs and materials for data collection
• Draft data collection fields and labels
• Prepare eCRFs, print matrices and eCRF completion guides along with other study materials for review
• Actively participate in study build meetings and study build planning
• Prepare eCRF migrations and associated documentation as needed for updates
• Perform batch upload and data merge activities, as well as validation in support of studies converting from a prior system to an EDC system
• Other duties as needed

Reports to:

EDC Study Build Division Manager

Controls over position:
The EDC Study Build Division Manager will assign an EDC Study Builder to a study at the request of a Protocol Data Manager. Once the EDC Study Builder has been assigned, the Protocol Data Manager will submit requests for eCRF creation and updates. The EDC Study Builder is charged with maintaining the eCRFs and providing study materials to the Protocol Data Manager as needed.

Required qualifications:

• Ability to use Microsoft Word and Excel
• Ability to use Adobe In Design
• Ability to use Medidata Rave and other EDC systems
• Strong verbal and written communication skills
• Ability to organize and prioritize workload to meet or exceed deadlines

All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, national origin, disability, age, or veteran status.