[Hiring] Senior Clinical Data Manager @ICON plc

Role Description

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

• 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.
• Work 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.
• Oversee 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.

Qualifications

• 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.

Benefits

• 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.