External Data Services Manager
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
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & BenefitsICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
- 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
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
