EDC Clinical Trial Designer

IQVIA LLC; Durham (NC); On-site; USD 69,000 - 171,000; Full time

Job summary

IQVIA is seeking an EDC Clinical Trial Designer to create high quality data collection tools for new clinical trials and to facilitate design, development, documentation, testing and implementation of clinical eCRF databases. Form design using Oracle InForm/Central Designer or Veeva CDMS/Studio is expected.

The role emphasizes meeting timelines, applying SOPs, and collaborating with study teams to ensure quality and regulatory alignment, with focus on data management, trial design, and

Qualifications

• 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.
• 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.

Skills

Oral communication

Written communication

Attention to detail

Project management

Clinical data management

Education

BA/BS degree

Tools

Central Designer/Studio

Oracle InForm/Central Designer

Veeva CDMS/Studio

Job description

Job Summary

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, 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

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.

Minimum 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.
• 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.

Company

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com.

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is $68,500.00 - $171,100.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere.

Thank you for your interest in growing your career with us.