External Data Services Manager
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
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.
What You Will Do:
You will manage day-to-day clinical data science activities, supporting your team to deliver quality outcomes.
- 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 requirements 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.
Your Profile:
Required qualifications and experience:
Expertise in biomarker data types and/or Imaging data for oncology and non- oncology studies is preferred
Experience working with multiple data types/formats
Experience in managing clinical, biomarker data, eCOA and imaging data
Demonstrates broad knowledge of all applicable regulations including 21 CFR
Part 11, ICH-GCP Guidelines and CDISC standards for data collections.
Demonstrates advanced knowledge of Data Management processes and
industry best practices.
Advanced knowledge and experience with extracting data into SAS, CSV, andXML formats is required
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 maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
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, 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 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.
Are you a current ICON Employee? Please click here to apply
