New · posted Nov 5
ICON · Biotechnology
Principal Clinical Data & EDC Programmer
- Remote, US
- Remote
- Full-time
- Senior & Principal
The role
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.
- Mexico
- Colombia
- Canada
- United States
What you need
- 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
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
What you'll do
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
Pay and benefits
ICON didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
Rewards & Benefits
Competitive base salary and performance related incentives
Health and wellbeing programmes including medical, dental, and vision coverage where applicable
Retirement and pension plans
Life assurance and disability coverage
Employee assistance programmes and wellbeing resources
Learning and development opportunities through structured training and career pathways
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Working conditions
Location: Remote or Hybrid
Equal opportunity, accessibility and legal noticesICON's statements, word for word
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Are you a current ICON Employee? Please click here to apply
Job intelligence
The context around this role
Live data · November 5, 2026
Salary intelligence
How the pay compares
Senior & Principal roles in the US17 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $126,500 | $142,500 | $154,500 |
Comparisons: the base pay employers published on open Clinical Data Management roles at the same level on Regulatory Jobs, November 5, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Data Management
The general path across 62 open Clinical Data Management roles on Regulatory Jobs, with the titles they carry most. Not ICON's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 30 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership12
- Data and digital systems5
- Clinical trial conduct5
- Quality systems and risk4
- Documentation and SOPs3
- Validation and qualification2
- Lab testing and methods1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Data Management work in biotechnology, each linked to the agency or standards body that publishes it.
- CDISCCDISC standards(official source, opens in a new tab)SDTM, ADaM and CDASH, the clinical data standards FDA and PMDA require
- FDAFDA study data standards(official source, opens in a new tab)Required data standards and technical conformance for clinical study data
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trials
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ICHICH E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
- ICHMedDRA(official source, opens in a new tab)The ICH medical terminology for coding adverse events and medical history
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health data
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trials
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.gov
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- ICHICH E3(official source, opens in a new tab)Structure and content of clinical study reports
- ICHICH E2A to E2F(official source, opens in a new tab)Clinical safety data management, expedited reporting and periodic safety reports
- FDAFDA Electronic Submissions Gateway(official source, opens in a new tab)The agency-wide gateway for receiving electronic regulatory submissions
Company hiring pulse
ICON on Regulatory Jobs
- 140
- Open roles
- 65
- Distinct roles
- 32
- Locations
By discipline
- Clinical129 92%
- Quality7 5%
- Regulatory4 3%
By level
- Associate & Specialist59 42%
- Senior & Principal58 41%
- Manager18 13%
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Principal Clinical Data & EDC Programmer at ICON
Open until filled.