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Clinical System Designer

2+ years
Not Disclosed
10 Jan. 14, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Rave Database Programmer
Location: ICON
Job Type: Full-Time

About the Role:
Join ICON, the world’s largest and most comprehensive clinical research organization, powered by healthcare intelligence, as a Rave Database Programmer. In this role, you will integrate external data streams into clinical data repositories, enabling efficient analysis, reporting, and data submission. As a vital part of the team, you’ll support drug development through optimal data transfer, storage solutions, and ensure compliance with industry standards.

Key Responsibilities:

  • Analyze external data streams and propose efficient pathways for integration into clinical data repositories to support reporting and submission.
  • Collaborate with stakeholders to understand data collection goals and define data availability and consumption requirements.
  • Work with external data providers, Data Managers, and Clinical Programmers to drive data transfer, ingestion, transformation, and storage solutions.
  • Develop data transfer agreements, including complex data structures.
  • Define metadata for eSource data streams in a Metadata Repository, ensuring end-to-end oversight and identifying impacts of metadata deviations.
  • Address and resolve issues that could negatively impact study timelines, escalating to leadership as necessary.
  • Contribute to the development of procedural documents, job aids, and training materials to ensure compliance.
  • Lead or participate in cross-functional initiatives aimed at enhancing data acquisition capabilities.
  • Stay updated with industry trends and innovative technologies related to eSource and clinical data collection.
  • Shape and implement strategies to improve reusability, efficiency, and consistency across studies and therapeutic areas.

Qualifications:

  • BS/BA degree in Health Sciences or equivalent work experience; PhD preferred.
  • At least 5 years of experience within the Pharmaceutical, CRO, or Biotech industry.
  • Strong understanding of clinical trial processes and expertise in clinical trial setup and execution.
  • Experience with external data ingestion (Safety Lab, Biomarkers, eCOA/ePRO) preferred.
  • Knowledge of specialized data streams (omics data, flow cytometry) and data collection standards (CDASH, SDTM).
  • Ability to work across cultures in a global, matrix environment.
  • Strong project management skills, including defining objectives, managing cross-functional teams, and stakeholder negotiation.
  • Excellent verbal and written communication skills.
  • Creative thinking and adaptability to change and uncertainty.
  • Knowledge of industry-leading tools like Rave, and healthcare data exchange formats (HL7 FHIR) are assets.

What ICON Offers You:

  • Competitive salary and various annual leave entitlements.
  • Health insurance tailored to individual and family needs.
  • Retirement planning benefits and competitive savings opportunities.
  • Access to the TELUS Health Employee Assistance Program for global support.
  • Life assurance and country-specific optional benefits (e.g., childcare vouchers, gym memberships, subsidized travel passes).

Visit our careers page to learn more about the full range of benefits we offer.

ICON's Commitment to Diversity and Inclusion:
ICON is committed to building a diverse and inclusive workplace where all employees feel empowered to succeed. We believe in fostering innovation through diversity and ensuring equal consideration for all qualified applicants. ICON provides a discrimination-free workplace where all individuals, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, can thrive.

If you need reasonable accommodations due to a medical condition or disability, please let us know through the form on our careers page.

Interested in this role? We encourage you to apply, even if you don’t meet every single requirement. There’s a good chance you’re exactly what we’re looking for!