Medical Informatics Manager

Duration: 12 Months

Role responsibilities:

• Data Management POC for DSTI and Clinical studies in which we are included in

• Participates and contributes to the development of Clinical Outcome Assessments (COAs) for Electronic Data Capture

• Develops, Implements and Conduct data quality checks as needed for work/studies

• Works closely with the various stakeholders to understand evolving project portfolio needs, and integration into the 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.

• As a medical informaticist, ensure collection, organization, curation, storage and safeguarding of patient data from lab, 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.

• Tracks emerging study data and works closely with data science team to ensure the effectiveness of tools and data quality

• 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.

Basic qualifications:

• Master’s degree in Health Informatics, Computer Science, or Information Systems

• At least five years of technical experience, including:

o Python

o Unix/Linux environments

o Version control systems (ex. Git)

o AWS or other cloud-based development

o Electronic data captures (EDC) solutions, e.g., REDCap, Encapsia, Oracle Clinical, Medidata Rave

o Familiarity with pharmaceutical informatics standards like CDISC and MedDRA

• Strong interpersonal and leadership skills

• Demonstrate the ability to build consensus and drive change across the organization

• Hands-on experience with Clinical Data Management, including Case Report Form (CRF) design, CRF annotation, database design, data-entry, data validation, discrepancy management, medical coding, data extraction, database locking, and regulatory requirements

Preferred qualifications:

• Clinical trial experience

• Experience with electronic data captures (EDC) solutions, e.g., REDCap, Medrio

• Familiarity with medical informatics standards like CDISC

• Experience with AWS or other cloud-based development

• 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

Required skills:

1. Clinical Study Exp. /Data Management

2. Python

3. Amazon Web Services (S3) or Equivalent