Clinical Data Manager – Digital Medicine and Translational Imaging

Job Description: • Data Management POC for studies in which we are included in • Responsible for mapping local study dictionaries to CDISC Standards • Participate and contribute to the development of operational plans to ensure data quality and completeness • Develop, Implement, and Conduct data quality checks as needed for work/studies • Work closely with the various stakeholders to understand evolving project portfolio needs, and integration into the systems and requirements; supporting studies with a wide range of disease domains • Contribute technical expertise toward the design, implementation, and scaling up of sensor systems and analytics • As a medical informaticist, ensure collection, organization, curation, storage and safeguarding of patient data from lab, asset teams, and external collaboration studies is consistent with 21CFR part 11 • Contribute to the overall architecture of the existing data pipelines and workflows, recommends and implements improvements • Track emerging study data and works closely with data science team to ensure the effectiveness of tools and data quality • Manage own time to meet agreed targets • Work under general supervision. Performs assignments using established procedures and general instruction • Share learnings with key stakeholders and the scientific community through presentations and peer-reviewed publications Requirements: • Master's degree in Health Informatics, Computer Science, Information Systems, or similar field required • A minimum of 5+ years of technical experience required, including: Python, Unix/Linux environments, Version control systems (ex. Git), AWS or other cloud-based development, Electronic data captures (EDC) solutions, e.g., REDCap, Encapsia, Oracle Clinical, Medidata Rave • Familiarity with pharmaceutical informatics standards like CDISC and MedDRA • GCP experience • Strong interpersonal and collaboration skills • Demonstrate the ability to build consensus and be agile to changing circumstances and priorities • Hands-on experience with Clinical Data Management, including Case Report Form (CRF) design, CRF annotation, database design, data collection, data-entry, data validation, discrepancy management, medical coding, data extraction, database locking, and regulatory requirements Benefits: • Flexible work arrangements • Professional development opportunities