Clinical System Designer I

Posted 12 Days Ago
Be an Early Applicant
4 Locations
In-Office or Remote
Junior
Healthtech • Biotech • Pharmaceutical • Manufacturing
The Role
Designs and implements clinical systems for research trials, including CRFs, edit checks, dynamic checks, database specifications, and post-production changes. Reviews requirements, conducts quality control, leads specification meetings, supports timelines and change management, and mentors junior team members. Requires clinical research systems experience, clinical data management expertise, familiarity with Medidata Rave or Veeva EDC, CRF design capability, strong communication skills, and a relevant bachelor’s degree.
Summary Generated by Built In
Clinical System Designer I - Canada, Mexico, Colombia (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 are currently seeking a Clinical System Designer I to join ICON’s Full-Service IOD Clinical Data Science team. As a Clinical System Designer I at ICON, you will play a pivotal role in designing and implementing advanced clinical systems that enhance trial design and execution.

Locations:

  • Mexico
  • Colombia
  • Canada

What you will be doing:

  • Leading the design and development of clinical systems, ensuring alignment with study protocols and operational needs
  • Consolidates and completes the high-level system requirements documents and manages their review
  • Responsible for copying and modifying CRFs from standard libraries and other studies
  • Provides support and review for the re-use of library items
  • Responsible for development of custom CRF screens, Edit Check and Dynamic Check specification documents using prototyping methodologies as needed
  • Performs quality control peer reviews of database related specifications as needed and records comments appropriately
  • Lead eCRF and other specification review meetings
  • Utilizes edit checks from the appropriate library and modify the library edit checks to meet trial specific requirements
  • Programs more complex dynamic checks and discrepancy edit checks to meet trial specific requirements
  • Review all activity on an ongoing basis to identify out of scope tasks and bring to the attention of the CSL
  • Support the CSL in negotiation of timelines and decision making on the study
  • Assist in assessing impacts of post-production database related changes and compiling the change management documentation for review by project team leads
  • Drive the post-production database changes and release into production
  • Provide refresher training to junior team members as required
  • Review the activity and progress of team members who have been delegated activity
  • Travel (approximately 10 %) domestic and/or international

Your profile:

  • 1+ years of experience in the design and implementation of clinical systems within the clinical research industry
  • Expertise in data analysis and interpretation or Database Development, with proficiency in clinical data management systems and software
  • Knowledge of at least 1 Clinical Data Management System (Medidata Rave, Veeva EDC, etc.)
  • Functional knowledge of CRF design tools and ability to plan and design CDMS components directly from interpretation of medium complexity clinical trial protocols
  • Excellent written and verbal communication skills
  • Bachelor’s Degree in a relevant field
  • Equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated above. All employees must read, write, and speak fluent English and host country language.

* Please submit all applications in English *

#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

  • At least 1 year of experience designing and implementing clinical systems within the clinical research industry
  • Expertise in data analysis and interpretation or database development
  • Proficiency with clinical data management systems and software
  • Knowledge of at least one clinical data management system, such as Medidata Rave or Veeva EDC
  • Functional knowledge of CRF design tools
  • Ability to plan and design clinical data management system components from medium-complexity clinical trial protocols
  • Excellent written and verbal communication skills
  • Bachelor’s degree in a relevant field, or equivalent education, training, and relevant experience
  • Fluency in English and the host-country language
  • Legal right to work in the country where the role is based

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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