The Case Report Form (CRF) Designer will create high quality data collection tools. Design of eCRF forms using Oracle Central Designer (Version 1.2 and above)/InForm (Version 5.0 and above) as well as programming of edit checks is expected. In addition, the CRF Design Specialist will ensure that all relevant standard operating procedures, Incyte CRF Standards, process and trial-specific guidelines are implemented and utilized to help ensure that a quality work product is produced and timelines and deliverables are consistently met.
- Proficiency with the following in Central Designer
- Understanding detailed data collection requirements based on the protocol and input from study team members
- Working with libraries and creating new forms when suitable forms do not exist
- Producing annotated study books
- Workflow design and global conditions
- Programming edit checks
- Validation and deployment of study packages created using Central Designer to InForm test environment
- Test steps development and QC of individual study builds
- Understanding of activities needed for data integrations, local lab management, coding functionality
- Post production changes to the live trial
- Preferred to have experience with Inform Application and Database server administration for trial development.
- Ability to conduct meetings with the study team to communicate work scope, project timelines, and project specific requirements.
- Maintain a good working knowledge relative to regulatory requirements, industry trends, benchmarks, and best working practices in data management and database design by reading, participating in relevant training and/or association activities.
- BA/BS degree (Computer Science preferred)
- Minimum of 2 years of Clinical Data Management experience using electronic data capture systems
- Experience in programming edit checks in InForm/Central Designer is required
- Effective oral and written presentation and communication skills
- Strong attention to detail and a commitment to high quality work and customer service
- Ability to manage multiple project tasks and deliverables in a fast-paced environment
- Experience in the planning and management of clinical trials in the biopharmaceutical industry or a related field is preferred.
Familiarity with clinical research processes and CDISC/CDASH/SDTM standards is preferred.