Clinical Data Manager

20 hours ago


Cambridge, Massachusetts, United States Pioneer Data Systems Full time
Job Title: Clinical Data Manager

Pioneer Data Systems is seeking a highly skilled Clinical Data Manager to join our team in Cambridge, MA. As a Clinical Data Manager, you will be responsible for overseeing and monitoring digital health technologies and imaging data in clinical trials.

Responsibilities:
  • Operational and vendor engagement for BEST and Clinical studies
  • Contribute to overseeing and monitoring DHT-derived and/or imaging data into Pharmaceutical
  • Track emerging study data and works closely with data science team to ensure the effectiveness of tools and data quality
  • Develop 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 Pharmaceutical stakeholders to understand evolving project portfolio needs, and integration into the Pharmaceutical 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
  • Ensure collection, organization, curation, storage and safeguarding of patient data from BEST teams, 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
Requirements:
  • BA/BS degree in Health Informatics, Computer Science, Information Systems, or similar field
  • Experience with digital vendor management and operational monitoring of digitally derived data
  • Hands-on experience with data monitoring and vendor operations, data collection, data-entry, data-monitoring, data-validation, discrepancy management, data extraction, and IRB/regulatory requirements
  • A minimum of 3+ years of technical experience, including Python, Unix/Linux environments, 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
Preferred Qualifications:
  • Master's degree in health informatics, computer science, information systems or a similar scientific field
  • Clinical trial experience involving, operationalizing, deploying and monitoring digital health technologies and imaging associated data
  • Experience processing large data sets (including from digital health technologies) in a distributed computing environment
  • Experience with SQL or NoSQL-based technologies


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