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
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• 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
Apply tot his job
Apply To this Job