ICON plc

Senior Clinical System Designer

ICON plc$90K — $110K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • 5+ years of experience in clinical system design and implementation
  • Expertise in data analysis and database development
  • Proficient with at least one Clinical Data Management System (e.g. Medidata Rave, Veeva EDC)
  • Strong knowledge of CRF design tools and clinical trial protocols
  • Excellent written and verbal communication skills
  • Bachelor’s Degree in a relevant field

Responsibilities

  • Lead design and development of clinical systems per study protocols
  • Consolidate and manage high-level system requirements documents
  • Copy and modify case report forms (CRFs) from libraries and studies
  • Support and review the reuse of library items
  • Develop custom CRF screens and specifications using prototyping methods
  • Perform peer reviews of database specifications and document comments
  • Coordinate eCRF and specification review meetings

Benefits

  • Comprehensive total rewards package
  • Health and wellbeing programmes including medical, dental, and vision coverage
  • Retirement and pension plans
  • Life assurance and disability coverage
  • Employee assistance programmes and wellbeing resources
  • Learning and development opportunities through structured training
Full Job Description
Senior Clinical System Designer - Canada (Remote) We are currently seeking a Senior Clinical System Designer to join ICON’s Full-Service IOD Clinical Data Science team. As a Senior Clinical System Designer at ICON, you will play a pivotal role in designing and implementing advanced clinical systems that enhance trial design and execution. Location: Canada (Remote) 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 - Travel (approximately 10%) domestic and/or international Your profile: - 5+ 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.) - Excellent 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 #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 to read more about the benefits ICON offers.

About ICON plc

ICON plc is a global provider of drug development and commercialisation services to the pharmaceutical, biotechnology and medical device industries. The company specialises in the strategic development, management and analysis of programs that support clinical development. ICON has approximately 15700 employees in 40 countries. The company was founded in Dublin, Ireland in 1990 and is headquartered in Leopardstown, Dublin. ICON has been publicly traded on the NASDAQ since 1998.
Learn more about ICON plc
Size
39,300 employees
Market Cap
$16.2 billion
Industry
Net Income
$332.3 million
Founded
2017
5 Year Trend
+26.9%
Revenue
$2.7 billion
NASDAQ

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