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Clinical Data Manager

4 weeks ago

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

We are seeking a highly skilled Clinical Data Manager to join our team at Pioneer Data Systems. As a Clinical Data Manager, you will play a critical role in the deployment and scaling of digital and imaging solutions into clinical trials.

Key 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 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 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, and 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
Physical/Mental Requirements:
  • Ability to perform mathematical calculations and ability to work with large complex data sets
Physical Position Requirements:
  • Office work