EDC Clinical Trial Developer

JobDiva, Inc.; Wilmington (DE); On-site; USD 90,000 - 130,000; Full time

Job summary

Kaztronix is seeking an EDC Clinical Trial Developer to design data collection tools for new trials and develop eCRF forms using Veeva CDMS/Studio. You will program edit checks, build forms, and generate complex reports via Veeva Workbench to support timely study delivery.

Responsibilities include deployment validation, study design testing, and communicating requirements to the study team. A strong data management background and CDISC knowledge are preferred.

Qualifications

• BA/BS degree in CS or related field.
• Minimum 2 years Clinical Data Management with eDC experience preferred.
• Basic programming experience required.
• SQL and/or CQL experience.
• Strong communication skills and attention to detail.
• Ability to manage multiple tasks in a fast-paced environment.
• Familiarity with CDISC/CDASH/SDTM preferred.

Responsibilities

• Design eCRF forms using Veeva Studio and develop forms workflow.
• Program basic edit checks and set up simple integrations.
• Create complex reports using Veeva Workbench and SQL.
• Validate deployments to test and live environments.
• Produce annotated study books and maintain documentation.
• Communicate scope, timelines and requirements to study teams.

Skills

Data management

Communication

Attention to detail

Project coordination

Education

BA/BS degree in CS or related field

Tools

Veeva Studio

Veeva Workbench

SQL

CQL

Job description

Job Summary (Primary function)

The EDC Clinical Trial Developer 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 Veeva CDMS/Studio as well as programming of edit checks and basic set up of integrations is expected. Responsibilities will include report creation using a form a SQL in the Veeva Workbench reporting tool. In addition, the EDC Clinical Trial Developer will ensure that all relevant standard operating procedures, 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.

Essential Functions of the Job (Key responsibilities)

• Proficiency with the following in 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.
  • 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.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• BA/BS degree (Computer Science degree preferred). Commensurate experience will be considered.
• Minimum of 2 years of Clinical Data Management experience using electronic data capture systems is preferred but not required.
• 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.
• 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.

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.