Principal Clinical Data & EDC Programmer

ICON plc; United States; Hybrid; USD 140,000 - 210,000; Full time

Job summary

ICON plc, a global healthcare intelligence and clinical research organisation, seeks a Principal Clinical Data & EDC Programmer to lead CDMS programming, eCRF checks, and analytics for trials. Remote or hybrid work across the Americas is supported while maintaining data integrity and efficiency.

You will mentor programmers, develop vendor data handling programs, and collaborate with data managers, statisticians, and PMs to ensure seamless integration of programming across study teams.

Qualifications

• 10+ years of experience with EDC programming (Medidata Rave and/or Veeva).
• Proficiency with SQL and/or SAS for vendor data imports or DM reconciliation.
• Experience leading studies, training, and mentoring junior programmers.
• Strong problem-solving and communication skills in a fast-paced, cross-functional environment.
• Attention to detail and high-quality results.
• Experience with R and Python (preferred).
• Bachelor’s degree in a relevant field.

Responsibilities

• Develop, validate, and maintain programming solutions for CDMS/EDC systems and analytics in clinical trials.
• Create data transfer programs and data validation outputs.
• Collaborate with data managers, project managers, and biostatisticians to integrate programming solutions.
• Serve as primary contact during study set up and maintenance for system programming questions.
• Mentor and train other programmers; share knowledge via presentations and training materials.
• Lead innovations in analytical techniques, automation, and process improvements.

Skills

EDC programming

SQL

SAS

Python

R

Leadership

Training & mentoring

Problem solving

Communication

Bid defense

Education

Bachelor’s degree in a relevant field

Tools

Medidata Rave

Veeva

SQL

SAS

Python

R

Job description

Principal Clinical Data & EDC Programmer - Canada, Mexico, Colombia, United States (Remote)

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

We have an incredible opportunity for a Principal Clinical Data & EDC Programmer to join ICON’s Full-Service IOD Clinical Data Science Systems team. The Principal Clinical Data & EDC Programmer will lead the programming of clinical data management systems (CDMS) (including dynamic eCRF checks and edit checks), non-CDMS components (including custom programs, reports, and integrations), and analytics solutions. They will also develop and maintain programs required for handling external vendor trial data.

Location: Remote or Hybrid

• Mexico
• Colombia
• Canada
• United States

What you will be doing:

• Develop, validate, and maintain programming solutions for CDMS (EDC systems such as Rave/Veeva), data validation outputs, data review/risk management outputs, custom reports, and programs in clinical trials, using SAS, R, and/or Python
• Develop and maintain programs required for handling external vendor data, using SAS, R, and/or SQL
• Perform extracts of data from CDMS and create data transfer programs
• Collaborate with data managers, project managers, and biostatisticians, among other positions, to ensure the integration of programming solutions into the overall data management process
• Act as a primary point of contact during the study set up and maintenance phase for system programming related questions by the project team
• Actively participate in internal and external meetings and provide constructive feedback to peers, team leads, and functional management
• Act as mentor and provide ad hoc guidance, training, and support to other programmers
• Support knowledge sharing within the Programmers group through presentations and preparation of training materials
• Assist in the development and implementation of improvements to technical systems and processes within an SME role
• Stay updated on advancements in programming languages and data management tools to enhance operational efficiencies
• Provide final-level technical review and consultation for complex programming activities
• Provide technical leadership for cross-study and program-level analytics initiatives
• Lead implementation of innovative analytical techniques, automation strategies, and process improvements

Your profile:

• 10+ years of experience with EDC programming (Medidata Rave and/or Veeva) and data validation outputs, data review/risk management outputs, custom reports, and programs in clinical trials
• Proficiency with SQL and/or SAS programming for vendor data imports or creating DM reconciliation outputs
• Experience leading studies, providing training, and mentoring junior programmers
• Strong problem-solving and communication skills with the ability to work collaboratively in a fast-paced, cross-functional environment
• Excellent attention to detail and organizational skills, with a commitment to delivering high-quality results
• Experience with bid defense meetings (preferred)
• Experience programming with R & Python (preferred)
• Bachelor’s degree in relevant field

#LI-TP1

#LI-Remote

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here