External Data Services Manager

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.