Clinical Data Manager, Digital Medicine and Translational Imaging - FSP - East Coast US
Job Summary:
We are looking for a self-directed professional to support clinical data management efforts for the biomeasures endpoints projects. This individual will be responsible for acquiring, processing, and reviewing patient data and records, organizing clinical data forms, implementing data management plans including data preparation and validation activities and define ways to improve operational processes for these activities. They will act independently and in collaboration with study teams seeking to develop and validate novel digital endpoints across different therapeutic areas.
In close partnership with colleagues from Research teams from Research and Development, They will play a key role in the deployment of novel digital endpoints into clinical studies, collection, management and analysis of sensor data, both in patients and healthy volunteers. This role will be central to the deployment and scaling of digital solutions into clinical trials where these technologies may be utilized as efficacy endpoints and provide value to key stakeholders including patients, physicians, payers.
Key Responsibilities:
• 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.
Minimum 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
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We are looking for a self-directed professional to support clinical data management efforts for the biomeasures endpoints projects. This individual will be responsible for acquiring, processing, and reviewing patient data and records, organizing clinical data forms, implementing data management plans including data preparation and validation activities and define ways to improve operational processes for these activities. They will act independently and in collaboration with study teams seeking to develop and validate novel digital endpoints across different therapeutic areas.
In close partnership with colleagues from Research teams from Research and Development, They will play a key role in the deployment of novel digital endpoints into clinical studies, collection, management and analysis of sensor data, both in patients and healthy volunteers. This role will be central to the deployment and scaling of digital solutions into clinical trials where these technologies may be utilized as efficacy endpoints and provide value to key stakeholders including patients, physicians, payers.
Key Responsibilities:
• 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.
Minimum 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
#LI-CF1
#LI-REMOTE
Apply tot his job
Apply To this Job