EDC Clinical Trial Developer

Summary

Kaztronix LLC is an equal opportunity employer offering a remote EDC Clinical Trial Developer role. The position develops and implements electronic clinical trial data collection tools and eCRF databases using Veeva CDMS/Studio, including form design, edit checks, integrations, reporting, testing, and deployment. The role also coordinates with study teams and ensures adherence to applicable standards, procedures, and timelines.

Responsibilities

• 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
• Building the workflow design, dynamic forms and events
• Programming of basic edit checks
• Validation and deployment of the forms and schedule study design created using Central Designer/Studio to test and live environments
• Test steps development and QC of edit checks
• Ability to set up integrations
• Ability to use Veeva’s Workbench reporting tool to create complex reports
• 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

Skills

• BA/BS degree (Computer Science degree preferred). Commensurate experience will be considered
• Basic programming experience is required
• SQL and/or Veeva's reporting language (CQL) experience
• 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 measured error rate of less than 20%
• Ability to manage and deliver multiple project tasks in a fast-paced constantly changing environment
• Minimum of 2 years of Clinical Data Management experience using electronic data capture systems is preferred but not required
• 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

Qualifications

Must Haves

• BA/BS degree (Computer Science degree preferred). Commensurate experience will be considered
• Basic programming experience is required
• SQL and/or Veeva's reporting language (CQL) experience
• 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 measured error rate of less than 20%
• Ability to manage and deliver multiple project tasks in a fast-paced constantly changing environment

Nice to Haves

• Minimum of 2 years of Clinical Data Management experience using electronic data capture systems is preferred but not required
• 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

Benefits

• Remote work arrangement