Senior Clinical Data Science Lead

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

What you will be doing:

The Clinical Data Lead will serve in a support‐level capacity on a Clinical Data Management team to provide efficient and quality clinical data management products. Support the design, specifications, and development of eCRFs, ensuring adherence to client standards throughout. Coordinate the development and testing of clinical data management systems edit checks and listings/reports/tools for data review and discrepancy management activities. Support the development of Data Management Plan documents that will ensure delivery of accurate, timely, consistent, and high‐quality clinical data.

• Take part in study kick off (internal and external) meeting along with the DMPM
• Read, ensure understanding and adhere to the study protocol, contract and scope of work for all task during set-up, maintenance and close-out of the study
• Assist the DMPM with revenue recognition and revenue forecasting process on a monthly basis
• Lead the development of specifications, implementation, and testing for the eCRF or paper CRF
• Lead the development of specifications, implementation, and testing for the edit checks and data review and oversight listings (DVS)
• Lead development of the data management plan and study specific procedures
• Ensure effective implementation of standard metric and status reporting on the study
• Lead development of specifications for custom reporting on the study
• Perform project-planning tasks and support the DMPM in the development of the project plan and timelines
• Set up and maintain data management study files for inclusion in the Trial Master File, ensuring these are maintained in an audit ready state for review by Sponsor, Regulatory or ICON Auditors
• Adhere to the project plan and timelines in the implementation of study tasks during set-up, maintenance and close-out of the study
• Key point of contact for the sponsor and the study team on day to day study data issues, eCRF design, edit checks, and other implemented components
• Organize and lead regular data management team meetings, both internal and with the sponsor and the DMPM
• Attend and provide an update for data management services at cross-functional study team meeting both internally and with the sponsor and the DMPM
• Maintain and track meeting minutes, issues and decisions logs, and escalations

You Possess:

• Bachelor’s degree preferred, preferably in a scientific discipline such as Statistics, Mathematics, Economics, Computer Science, IT, Biology, Social Science, etc.
• 4+ years of Clinical Data Management experience
• Robust experience with EDC (E.g. Medidata Rave) and use of Data Review tools such as elluminate, J‐Review or Business Objects required
• Deep understanding of drug development and biopharmaceutical industry required
• Strong technical skills, including experience working with using Microsoft Excel functionality
• Excellent written and oral communication 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/benefitsICON, including subsidiaries, is an equal opportunity and inclusive employer and 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 or submit a request here.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.