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

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

Clinical Data Manager – Digital Medicine and Translational Imaging

Key skills