Senior Clinical Data Manager

Senior Clinical Data 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. As a Clinical Data Science Lead at ICON, you will drive data science initiatives within clinical trials, ensuring that our analyses provide meaningful insights that inform strategic decisions.

Key Responsibilities:

• Serve in a support-level capacity on a Clinical Data Management team to provide efficient and quality clinical data management products. Support the design, specifications, and development of eCRFs, ensuring adherence to company standards.
• Coordinate the development and testing of clinical data management systems edit checks and listings/reports/tools for data review and discrepancy management activities.
• Support the development of Data Management Plan documents that will ensure delivery of accurate, timely, consistent, and high-quality clinical data. Works with Third Party/External data Vendors to complete the set-up of data import and reconciliation processes.
• Perform comprehensive review of all data generated from the clinical study including Third Party/External data, SAE data and local lab data, as applicable. Oversees quality control procedures. Develop and maintain strong communications and working relationships with CDM team.
• Effectively manage project timelines and quality.
• Provide reports, status updates, feedback, and advice to key study stakeholders on the progress of data cleaning and risk identification/mitigation activities.
• Ensure CDM activities are performed in compliance with Good Clinical Practice, ICH Guidelines.
• Apply appropriate best practices and independently offer project solutions to the study team.
• Support the filing of eTMF documentation to ensure that an inspection ready environment is maintained throughout the study lifecycle.
• Provide back up support for Principal Clinical Data Lead as required.

Your Profile:

• 4+ years of Clinical Data Management experience
• Ability to work under pressure demonstrating agility through effective and innovative team leadership
• Robust experience with EDC (E.g. Medidata Rave) and use of Data Review tools such as elluminate, J-Review or Business Objects required
• Experience in Phase I/II
• Neurology experience would be desirable.
• Extensive experience in Study startup.
• Strong technical skills, including experience working with using Microsoft Excel functionality
• Fluent English (oral and written)
• Strong understanding of drug development and biopharmaceutical industry required.
• High attention to detail including proven ability to manage multiple, competing priorities
• Excellent written and oral communication skills