Senior Clinical Data Manager: Data Strategy & Quality Lead

Remote Worker LTD.; United States; Remote; USD 110.000 - 160.000; Vollzeit

Benefits dieser Stelle

Competitive base salary

Health and wellbeing programmes

Retirement and pension plans

Life assurance

Employee assistance programmes

Learning and development opportunities

Zusammenfassung

ICON Strategic Solutions is seeking a Senior Clinical Data Manager to join a sponsor-dedicated model supported by ICON’s global expertise. You will drive data science initiatives within clinical trials, ensuring analyses provide insights for strategic decisions.

Responsibilities include CDM support, eCRF development, data review, and ensuring GCP compliance. This remote-friendly role emphasizes timely data delivery, quality management, and collaboration with cross-functional teams.

Aufgaben

• 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.

Jobbeschreibung

ICON Strategic Solutions is seeking a Senior Clinical Data Manager to join a sponsor-dedicated model supported by ICON’s global expertise. You will drive data science initiatives within clinical trials, ensuring analyses provide insights for strategic decisions.

Responsibilities include CDM support, eCRF development, data review, and ensuring GCP compliance. This remote-friendly role emphasizes timely data delivery, quality management, and collaboration with cross-functional teams.