Senior Clinical Data Manager

3 days ago

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

Location: Cambridge, MA

Duration: 12 months Contract

Payrate: $55- $76/hr. on w2 without benefits

Job Summary

We are seeking a highly skilled and experienced professional to support the operationalization and monitoring of digital health technologies and imaging data within clinical trials. The successful candidate will be responsible for assisting in the setup, vendor management, and data monitoring of digitally derived data, as well as developing and implementing operational plans to ensure data quality and completeness.

Key Responsibilities
  • Operational and vendor engagement POC for BEST and Clinical studies
  • Contributes to overseeing and monitoring DHT-derived and/or imaging data into Client
  • 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 the various Client stakeholders to understand evolving project portfolio needs, and integration into the Client systems and requirements; supporting studies with a wide range of disease domains
  • 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
  • Manages own time to meet agreed targets
  • Works under general supervision
  • Performs assignments using established procedures and general instruction
  • Shares learnings with key stakeholders and the scientific community through presentations and peer-reviewed publications
Organizational Relationships

Partners with colleagues in BEST, Digital Quantitative Sciences, Clinical Data Sciences, Data Acquisition, Biostatistics, Development Operations and Legal to ensure excellence in development and translation of these clinical research plans into efficiently delivered studies.

Technical Skills 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.

Physical Position Requirements

Office work

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