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Lead the development and implementation of advanced data science solutions and Data Transfer Specifications (DTS) for clinical trials. Manage external data providers and ensure data structures are consistent, compliant with CDISC standards, and aligned with study timelines.
Requires expertise in clinical data science programming with a focus on external data management and regulatory agency requirements. Candidates must be able to oversee vendors and collaborate cross-functionally to ensure data integrity and harmonization.
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
As a Senior Lead Clinical Data Science Programmer at ICON, you will be instrumental in leading the development and implementation of advanced data science solutions for clinical trials.
You will manage day-to-day clinical data science activities, supporting your team to deliver quality outcomes.
Key responsibilities include:
Lead the development of Data Transfer Specifications (DTS) documents to align external data providers and research partners on the required structure for new data. This includes:
Authoring the DTS, responding to external data providers and internal stakeholder queries to ensure
data will be delivered in the correct format and structure.
Track DTS status with external data providers across different data types and programs and ensure data completion dates are met for study timelines and deliverables.
Ensuring data structure based on the type(s) of data being used is consistent and compliant with appropriate data templates.
Ensuring data structure is consistent across each data provider and comply with appropriate data templates.
Support data reconciliation and data structure inquiry resolution.
Liaise cross functionally to facilitate the creation of new test codes.
Participate in the Clinical Study Team as an extended team member.
Oversee and train in the use of the DTS and other supplemental documents.
Contribute to improvement initiatives as it relates to external data process.
Ensure study teams adhere to CDISC standards as it relates to external data.
Comply with all pertinent regulatory agency requirements (Understand clinical protocols and requirement for Biomarkers/Imaging/eCOA data, blinding and analysis expectations).
Process change requests to update existing DTS.
Improve templates for existing DTS to ensure data harmonization and downstream analytics.
Provide external data management oversight to vendors, providing a pathway for functional discussions, partnership level processes & standards, portfolio status, communication, and escalation.
Review and contribute to eCRF and EDC builds as it relates to external data requirements.
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Are you a current ICON Employee? Please click here to apply
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
Offices: ICON plc, South County Business Park, Leopardstown, Dublin, D18 X5R3, IE · 123 Smith Street, Farmingdale, New York NY 11735, US · Block 2, Hamilton House, National Technology Park, Limerick, V94 TRW8, IE · 100 Longwater Avenue, Green Park, 3rd Floor, North and South Wings, Reading, England RG2 6GP, GB · 1 Almondview Office Park, West Lothian, Livingston, EH54 6SF, GB
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