EDC Developer (Client dedicated)

As an EDC Developer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Design, develop and validate clinical trials in EDC
• Manage edit check specifications and configure edit checks at the trial level
• Execute UAT scripts to test the setup of the clinical study or EDC Platforms
• Configure different instances of study (eg: UAT, production, testing etc.,)
• Facilitate user access requests for study teams
• Setup and manage blinded and unblinded study configurations in EDC
• Serve as SME for all EDC database related activities at the trial level
• Setup, configure, validate and integrate other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc.,
• Ability to troubleshoot database setup as per study needs
• Perform Impact Assessment for post production changes
• Prepare, test, and implement post production changes as per study needs
• Assist driving the adoption of new capabilities and business processes
• Serve as the contact for Clinical Technology vendors to ensure established milestones are met with the highest degree of quality.
• Work with leadership to solution issues or gaps affecting the delivery of clinical trials
• Lead technology vendor oversight activities.
• Partner with appropriate team members, technology vendors, and CRO partners to avoid and resolve risks.
• Confirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents
• Participate in preparing function for submission readiness and be prepared to represent Clinical
• Trial Configuration group in a formal inspection or audit.
• Track study deliverables and evaluate study metrics to mitigate risk for major data management deliverables.
  

You are:

• Bachelor's degree or related experience.
• Knowledge of drug development process.
• 6+ years’ experience in Data Management, Clinical Programming, or other Clinical Research related fields with a minimum of 4 years’ experience in EDC programming
• Hands-on experience with Veeva(mandatory), Medidata Rave, Oracle Inform, etc.
• Experience programming in CQL, CDB, working with JSON format and/or C# is preferred but not required
• Experience integrating other clinical trial modules (eg: lab, safety, IRT, coding, etc.,) with the EDC system
• Understanding of industry standard technologies to support Clinical Development needs (e.g. CTMS, SAS, R or Python, Data Warehouses, SharePoint)

What 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/benefits

At 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-accommodations

Interested 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.