Clinical System Designer

As a Rave Database Programmer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Analyze data and content from external data streams and propose efficient pathways to integrate relevant data into  clinical data repository to support analysis, reporting and submission of data.
• Liaise with key data stakeholders to understand the purpose of data collection and agree upon data availability and consumption requirements.
• Liaise with external data providers, Data Managers and Clinical Programmers to drive optimal data transfer, ingestion, transformation and storage solutions.
• Oversee the development of data transfer agreements
• Take the lead in developing data transfer agreements for new data stream types or for data streams with need for understanding complex data structures and/or content.
• Define data collection metadata for eSource data streams in a Metadata Repository; Ensure end to end oversight on full data flow; Identify downstream impact of data collection metadata deviations from standards.
• Identify and resolve issues that may negatively impact study timelines. Escalate to leadership as needed.
• Develop procedural documents, job aids and training material as part of a compliant environment
• Lead or participate in cross-functional improvement initiatives to develop an industry leading data acquisition capability.
• Keep abreast of relevant industry trends and innovative technologies related to eSource
• Actively contribute to the shaping and implementation of the Data Acquisition strategy, improving re-usability, efficiency and consistency of data acquisition tools across studies and therapeutic areas

You are:

• BS/BA degree or higher in Health Sciences or equivalent work experience is required. PhD preferred.
• Relevant experience within the Pharmaceutical, CRO or Biotech industry is required, see below for details
• Good understanding of overall drug development process with proven expertise in clinical trial setup and execution
• Experience with collecting Safety Lab, PK, Biomarkers, ECG, eCOA/ePRO or other external data ingestion within clinical trials is preferred
• Experience with collecting data from Digital Health technologies and/or RWD are assets
• Deep expertise in specialized data streams (omics data, flow cytometry, …) is an asset
• Strong knowledge of GCP/ICH guidelines
• In dept knowledge of data collection and submission industry standards (CDASH, SDTM) is required
• Ability to work in a global setting across different cultures within a matrix environment
• Demonstrated experience in working with external data providers within a clinical study setting
• Strong project management knowledge (defining objectives and deliverables, managing a cross-functional project team, managing stakeholders, negotiating, leading with influencing)
• Excellent verbal and written communication skills
• Effectively cope with change (ability to deal with ambiguity, shift gears comfortably, decide and act without having the total picture, and handle risk and uncertainty)
• Ability to think out of the box with creative and innovative mindset
• A team player, able to motivate and empower others
• Working knowledge of industry leading eCRF tools (Rave) is preferred
• Knowledge of EHR to EDC middleware technologies (Clinical Pipe, …) or health care data exchange formats (HL7 FHIR, …) are assets
• Experience working with a clinical metadata repository and understanding of end-to-end clinical metadata concepts are assets

(Minimum of 5 years of DM experiences & mid-level relevant skills)

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, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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, color, 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.