As an External Data Services Manager 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.

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. 

Your Profile:

You will have solid clinical data science experience, with the ability to manage competing priorities and develop your team.

Required qualifications and experience:

• Minimum 8+ years of experience in external data services

• 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.