EDC Clinical Trial Designer

ProPharma•Raleigh, NC

2d•Hybrid

About The Position

The EDC Clinical Trial Designer will create high quality data collection tools for new clinical trials and facilitate activities related to the design, development, documentation, testing and implementation of clinical eCRF databases. Design of eCRF forms using Oracle InForm/Central Designer or Veeva CDMS/Studio is expected. In addition, the EDC Clinical Trial Designer 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.

Requirements

BA/BS degree. Commensurate experience will be considered.
Minimum of 2 years of Clinical Data Management experience using electronic data capture systems.
Effective oral and written presentation and communication skills.
Strong attention to detail and a commitment to high quality work, customer service and getting things right the first time with minimal errors.
Ability to manage multiple project tasks and deliverables in a fast-paced constantly changing environment.

Nice To Haves

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.

Responsibilities

Proficiency with the following in Central Designer/Studio
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.
Basic understanding of workflow design, dynamic forms and events.
Validation of study design for forms and schedule design.
Test steps development and QC of forms.
Basic understanding of activities needed for data integrations, local lab management, coding functionality.
Input into design of post-production form changes to the live trials.
Apply lessons learned from one study build to the next
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.