Senior Clinical System Lead

The role defines and facilitates the participant data journey, identifying participant data sources, transport methods, ingestion to client's ecosystem and mitigating potential challenges to ensure understanding, consistency and integrity of the participant data. The role will collaborate with technical and clinical teams across client's to define participant data requirements and challenges to provide short- and long-term solutions and be a subject matter expert within data management and statistics to facilitate effective data use and risk mitigation.

A key part of the study team providing technical and procedural guidance on data ingestion and chain of clinical data custody; will be front facing with CRO’s, vendors and internal teams.
• Identify participant data sources and document; creation of study data flow maps to show the clinical data journey. Input to technical data specifications for data ingestion and use at
client.
• Primary point for nonstandard data ingestion and defining the data demand with enablement teams – internal and external facing
• Define and conduct data ingestion reconciliation against data transfer specifications
• Perform Risk Assessment for study-level participant data content and provide guidance on risk mitigation. Assess that the right data is being collected and educating the study teams
• Support digital health technologies and eSource data use providing set up and technical support to the wider teams and maintaining data integrity, input to long term solution planning.
• Assess and define new and existing strategic vendors to support data ingestion and data quality; be part of the assessment team to understand vendor capabilities and limitations.
• Work closely with data enablement teams on data ingestion, harmonization, transformation, validation, and automation for the Clinical Data platform
• Be a key contributor to internal business and process improvement by ensuring compliance to latest technology and regulatory guidance. Involvement in initiative implementation including digital protocol, automation, tokenisation, data optimisation, workflow definition.
• Ensure that the data governance framework is followed for participant data.

Strong knowledge of modern data management platforms and technologies, including Big Data, Lakehouse, and modern data ingestion and integration.

Must have experience with clinical data sets, EDC and non-crf data, and have strong analytical skills with the ability to work with a variety of large and complex datasets including (but not limited to) basic research datasets and clinical data.

Experience: Minimum of 4 years within clinical data management and data acquisition, preferably in the BioPharma industry. Ideal candidate will have 7+ years of experience.

Education: Bachelor’s degree in Computer Science, Data Science, Statistics, or a related field

Important Information for Applicants:

• This role does not offer remote work and is not open to freshers.

• Please review the job description carefully before applying.

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.