Clinical Data Enablement Manager

Clinical Data Enablement Manager

About the role

Clinical Data Enablement Manager

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

We are currently seeking a Clinical Data Enablement Manager (FSP) to join our diverse and dynamic team.

You will play a key role in supporting the operation and continuous improvement of clinical data pipelines across cloud-based data lake and data warehouse environments.

What You Will Be Doing:

• Supporting end-to-end clinical data pipelines across data lake and warehouse environments, including building, running, monitoring, maintaining and troubleshooting pipelines to ensure stable and traceable operations.
• Developing and enhancing cloud-based ETL/ELT pipelines using AWS and Azure for data ingestion, transformation and delivery, following established standards and frameworks.
• Supporting operational activities including monitoring and alerting, incident triage, root cause analysis and the implementation of corrective and preventive actions.
• Implementing automation for scheduling, repeatable data ingestion and automated quality checks to improve reliability and timeliness.
• Designing, developing and maintaining operational dashboards and data visualisations to support pipeline health monitoring, data quality oversight and stakeholder reporting.
• Supporting vendor and cross-functional integrations by implementing data transfers to agreed specifications, performing validation and reconciliation, and escalating issues where required.
• Collaborating with downstream teams, including Statistical Programming, SDTM, Analytics and Clinical Data Programming, to understand data requirements and deliver datasets and exports according to required formats, structures and timelines.
• Contributing to the timely and high-quality delivery of clinical data and supporting the tracking and reporting of operational KPIs, including timeliness, pipeline success rates and defects.
• Following controlled documentation and change management practices for regulated clinical processes and supporting GxP and CSV activities through appropriate documentation, testing evidence and traceability.
• Applying data integrity principles, including ALCOA+, and adhering to access control, audit trail and logging requirements in collaboration with Quality, Compliance and IT teams.

Your Profile:

• Bachelor’s degree or equivalent, with 5+ years of experience in data engineering, data pipeline development/operations and multi-source data integration. Experience within clinical research or biopharma would be advantageous.
• Foundational SQL skills with an understanding of data modelling, data quality checks and integration patterns. Exposure to NoSQL technologies would be beneficial.
• Proficiency in Python, or alternatively R, with experience building or supporting data pipelines incorporating testing, logging and monitoring.
• Familiarity with Agile and SDLC methodologies, with experience using Jira and Confluence advantageous.
• Hands-on experience developing operational dashboards and data visualisations using tools such as Power BI, Tableau and/or QlikView, including an understanding of data refresh, access controls and performance considerations.
• Awareness of clinical data standards such as CDISC, CDASH and SDTM, and an understanding or willingness to learn how these standards impact downstream clinical deliverables.
• Experience working with data formats including CSV, JSON and XML, alongside file- and API-based integrations, with the ability to follow transfer specifications and validate outputs.
• Exposure to AWS and/or Azure and modern data platforms such as Snowflake, Databricks and Spark, with the ability to work within established frameworks and standards.
• Working knowledge of GitHub or GitLab for version control. Exposure to CI/CD practices would be advantageous.
• Experience or exposure to GxP-regulated practices, including controlled documentation, change control and audit readiness, together with an understanding of data integrity requirements.
• Strong communication and collaboration skills, with an organised, detail-oriented and proactive approach and the ability to prioritise effectively and deliver to deadlines in a fast-paced environment.
• Previous experience supporting regulatory inspections or audits would be advantageous.

Location: Dublin, Warsaw, Johannesburg, Madrid, Tallinn, Reading Reference: JR164515

Note: This description does not include any external application instructions or contact information.