External Data Transfer Lead

ICON plc • Blue Bell, SD

4d

About The Position

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.

Requirements

• 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, and XML formats is required

Responsibilities

• 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.
• 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.

Benefits

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed