Data Management Developer (Client based)

ICON

  • Bruxelles Diegem, Brabant Flamand
  • CDI
  • Temps-plein
  • Il y a 14 jours
OverviewAs a Data Management Developer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.This is an hybrid role and it requires 3 days per week at the client’s office and 2 days working from home.
Office location: Diegem (Brussels area), Belgium OR Warsaw, PolandResponsibilitiesWhat you will be doing:
  • Develop and maintain data management documentation and guidelines in accordance with Good Clinical Practices (GCP) and Good Documentation Practices (GDP).
  • Provide subject matter expertise to project team members during all phases of project life cycle.
  • Develop, test, and maintain data management systems.
  • Provide subject matter expertise prior, during and post internal and external audits and inspections.
  • Collaborate with Data Managers, Study Teams, Vendors, and Site Staff to formulate Data Transfer plans for secondary data sources (e.g., Lab data, Site data).
  • Batch import agreed data sources into the EDC system.
  • Develop, program, validate, and maintain Medidata Rave EDC clinical trial databases in accordance with company standards.
  • Create EDC design specifications encompassing the data dictionary, event definitions, electronic consent, branching logic, edit checks, advanced query rules, calculated fields, and dynamic form and event rules.
  • Work with Data Managers and study teams to design and construct the EDC database based on global eCRF libraries.
  • Configure and optimize multiple patient user interfaces to support varying modes of data collection (eCOA- mobile device or tablet, EDC- laptop/desktop computer).
  • Conduct, test, and produce Rave EDC Migration activities as required.
  • Develop test scripts and coordinate EDC user acceptance testing (UAT) to ensure accuracy of database structure, content, and validation controls aligned with the original specifications.
  • Coordinate and manage the deployment of new or modified EDC databases into production.
  • Assist in mapping the EDC database to the company enterprise data warehouse.
  • As part of continuous improvement efforts, develop and implement EDC design standards to enhance quality and streamline database build proc
  • Be available to work on any BSC studies
  • Work according to BSC SOPs/WI
QualificationsYou are:University degree in Life Sciences, Clinical Research, Information Technology, or related fieldCertification required (mandatory): Medidata Rave EDC Certified Study Builder or at least the equivalent combination of both Medidata Rave Study Design and Build Essentials (SDBE)Minimum 3 years’ experience in a similar role within clinical research or data managementProven ability to manage and optimize EDC platforms in compliance with ICH-GCP and 21 CFR Part 11Strong cross-functional collaboration and stakeholder management skillsWhat ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:
  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs
  • Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsAt ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.https://careers.iconplc.com/reasonable-accommodationsInterested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

ICON