External Data Services Manager

The Manager, Data Management - External Data Services will play a critical role in Clinical Development through ensuring the delivery of appropriately structured external data, including but not limited to data from biomarkers, wearable devices, IRT, Imaging and Electronic clinical outcomes assessment - eCOA. The Manager, External Data Services will be responsible for effectively leading and supporting the Global Development Data Management team by serving as the primary contact to other line functions to oversee external data quality control, standardization, and integration for external data.

• 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
• Support data reconciliation and data structure inquiry
• Liaise cross functionally to facilitate the creation of new test
• Participate in the Clinical Study Team as an extended team
• Oversee and train in the use of the DTS and other supplemental
• Contribute to improvement initiatives as it relates to external data
• Ensure study teams adhere to CDISC standards as it relates to external
• 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
• Improve templates for existing DTS to ensure data harmonization and downstream
• 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

• Minimum of 8 years of external clinical data management/programming experience in biotechnology, pharmaceutical or health related industry and strong knowledge of database structures.
• 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
• 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
• BS Major/ Minor (Biology, Computer Science, programming, data management, scientific or analytic discipline or equivalent)

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.