Principal Clinical Data & EDC Programmer

Reposted Yesterday
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5 Locations
In-Office or Remote
Expert/Leader
Healthtech • Biotech • Pharmaceutical • Manufacturing
The Role
Leads EDC and clinical data management programming for clinical trials, including edit checks, validation outputs, vendor data integrations, custom reports, analytics, and data transfers. Provides technical leadership, final-level review, mentoring, training, stakeholder consultation, automation, and process improvements across studies and programs.
Summary Generated by Built In
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


Employment with ICON is contingent upon having the legal right to work in the country where the role is based.


Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.


Benefits may include:

  • 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

Benefits may vary depending on role and location.


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


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

Skills Required

  • 10+ years of experience with EDC programming, including Medidata Rave and/or Veeva, for clinical trial data validation, review, risk management, reporting, and programming
  • Proficiency in one or more of R, Python, SAS, and SQL
  • Experience leading, training, and mentoring junior programmers
  • Strong problem-solving and communication skills in a cross-functional environment
  • Excellent attention to detail and organizational skills
  • Bachelor's degree in a relevant field

ICON plc Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about ICON plc and has not been reviewed or approved by ICON plc.

  • Healthcare Strength — Benefits are described as comprehensive, with medical coverage and wellness initiatives highlighted. Larger sites are also associated with added wellness supports such as onsite fitness options and access to an employee assistance program.
  • Leave & Time Off Breadth — Time-off and flexibility provisions are positioned as a meaningful part of the total package, including vacation/annual leave and flexible work scheduling. Flexibility is sometimes cited as helping offset long hours in certain roles.
  • Retirement Support — Retirement and savings support is presented as a core component of the benefits package, including offerings such as pension arrangements in some locations and a U.S. 401(k) plan with company match. Financial planning resources are also emphasized as part of broader security benefits.

ICON plc Insights

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The Company
HQ: Dublin
34,685 Employees
Year Founded: 1990

What We Do

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.

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