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
Read Full Description