Job Title: External Data Services Manager
Location: Canada, United States (Remote)
About ICON plc:
ICON plc is a global provider of outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device, and government and public health organisations. At ICON, our focus is to accelerate the development of drugs and devices that save lives and improve quality of life.
Responsibilities:
Lead external data delivery processes for clinical studies involving biomarkers, wearable devices, IRT, Imaging, and eCOA.
Author Data Transfer Specifications (DTS) and manage alignment between external data providers and research partners regarding data structure requirements.
Act as the primary point of contact for internal stakeholders and external vendors to ensure data quality, consistency, and timely delivery.
Monitor DTS progression across programs, ensuring study timelines and deliverables are met.
Ensure uniform data structure across providers using compliant templates and CDISC standards.
Support data reconciliation processes and respond to structural inquiries.
Collaborate across functions to define and test new data workflows and structures.
Actively participate in Clinical Study Teams and contribute to protocol adherence and strategic planning.
Oversee vendor relationships and ensure consistency in data standards, issue resolution, and process documentation.
Review and enhance existing DTS templates for harmonization and downstream integration.
Manage updates to existing DTS and support change requests as needed.
Contribute to and lead external data-related improvement initiatives.
Ensure compliance with relevant regulations such as 21 CFR Part 11 and ICH-GCP.
Participate in the eCRF and EDC build reviews focusing on external data components.
Qualifications:
Bachelor's degree in Biology, Computer Science, Data Management, or a related scientific/analytic discipline.
Minimum of 8 years’ experience in clinical data management or programming within the biotech, pharma, or health industry.
Proven experience in managing multiple external clinical data types including biomarker, imaging, and eCOA data.
Advanced understanding of database structures, data standards (CDISC), and clinical data workflows.
Knowledge of oncology and non-oncology biomarker and imaging data is preferred.
Proficiency in data extraction into SAS, CSV, and XML formats.
Comprehensive understanding of applicable regulatory frameworks and data compliance standards.
Strong leadership, cross-functional communication, and vendor management skills.
What ICON can offer you:
Competitive salary with a comprehensive benefits package.
Various annual leave entitlements tailored to your region.
A wide array of health insurance offerings to meet individual and family needs.
Competitive retirement planning options to support long-term financial stability.
Access to the TELUS Health Employee Assistance Programme for well-being support.
Life assurance coverage and optional country-specific perks such as childcare vouchers, gym discounts, bike schemes, health assessments, and travel subsidies.
ICON is an equal opportunity employer and is committed to fostering a culture of inclusion and belonging. All qualified applicants will receive consideration without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or veteran status.
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