Clinical Data Manager

3 days ago

Cambridge, Massachusetts, United States Net2Source Inc. Full time
Job Title: Associate Director Data Operations

We are seeking a highly skilled Associate Director Data Operations to join our team at Net2Source Inc. This role will be responsible for overseeing the operational and vendor engagement aspects of our Digital Health Technology (DHT) and imaging components set-up and monitoring within clinical trials.

Key Responsibilities:
  • Operational and vendor engagement POC for BEST and Clinical studies
  • Contributes to overseeing and monitoring DHT-derived and/or imaging data
  • Tracks emerging study data and works closely with data science team to ensure the effectiveness of tools and data quality
  • Develops and contributes to the development of operational plans to ensure data quality and completeness
  • Develops, Implements and Conduct data quality checks as needed for work/studies
  • Works closely with various client stakeholders to understand evolving project portfolio needs, and integration into client systems and requirements
  • Contributes 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
  • Contributes 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
  • 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
Physical/Mental Requirements:

Ability to perform mathematical calculations and ability to work with large complex data sets.

Key Candidate Qualities:
  • MS Excel skill (required). Coupa and NetSuite experience
  • Willing to continue improving analytical skills and grow additional finance reporting skills
  • Demonstrates self-confidence and integrity in challenging work environment
  • Strong understanding of financial concepts
  • Excellent written and verbal communication as well as MS Office proficiency
  • Strong knowledge of Procurement and Financial software (Coupa, NetSuite)
  • Ability to solve problems, and optimize purchasing processes
  • Ability to handle multiple tasks simultaneously

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