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Clinical Data Analyst

2 months ago

Cambridge, Massachusetts, United States Pioneer Data Systems Full time
Job Description

Pioneer Data Systems is seeking a highly skilled Clinical Data Analyst to join our team. As a key member of our Digital Health Technology team, you will play a critical role in supporting the operational initiation, vendor and digital data monitoring, and data cleaning process efforts within our clinical trials.

Key Responsibilities:
  • Operational and vendor engagement point of contact for BEST and Clinical studies
  • Contribute to overseeing and monitoring DHT-derived and/or imaging data into Pharmaceutical
  • Track emerging study data and work 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 various Pharmaceutical stakeholders to understand evolving project portfolio needs and integration into Pharmaceutical systems and requirements
  • 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, recommend, and implement improvements
  • Manage own time to meet agreed targets
  • Work under general supervision
  • Perform assignments using established procedures and general instruction
  • Share learnings with key stakeholders and the scientific community through presentations and peer-reviewed publications
Requirements:
  • BA/BS degree in Health Informatics, Computer Science, Information Systems, or similar field
  • 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
  • At least three 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
  • Strong interpersonal and collaboration skills
  • Demonstrate the ability to build consensus and be agile to changing circumstances and priorities
Preferred Qualifications:
  • Masters 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
  • Comprehensive understanding of the landscape of data structures, medical ontologies, interoperability standards, and data processing tools
Work Schedule:

Monday - Friday, dayshift

Interview:

Preferably onsite, panel with team