Position at a glance
| Item | Details |
|---|---|
| Position | Senior Manager, Data Engineering and AI, Clinical and Diagnostic Data |
| Function | Clinical Data and AI |
| Level | Senior Manager |
| Employment type | Full-time |
| Employer | Hopkins MedTech Group LLC, doing business as Hopkins MedTech Compliance |
About the role
The Senior Manager of Data Engineering and AI builds and runs the data foundation for HMC's clinical performance studies and for its early-stage research in AI and digital health. Study data has to be complete, traceable and reproducible before a biostatistician or a regulator sees it; this role is accountable for that.
You will lead a small engineering team, set the technical direction, and stay close enough to the work to review a pipeline or a model evaluation yourself.
Responsibilities
- Design and operate pipelines that bring study data from electronic data capture systems, laboratory instruments and site records into a controlled, analysis-ready environment.
- Set the data model and standards for diagnostic studies, including CDISC conventions where a submission calls for them, with documented lineage from source record to reported result.
- Build automated data quality checks, reconciliation and query reports that clinical data managers and biostatisticians rely on.
- Keep data systems in a validated state: access control, audit trails, change control and 21 CFR Part 11 compliance, in partnership with Quality.
- Lead the engineering side of AI and digital health research, including dataset curation, labeling protocols, de-identification, model training infrastructure and versioned evaluation.
- Apply good machine learning practice to model work: locked test sets, subgroup performance analysis, bias assessment and documentation that a regulatory reviewer can follow.
- Protect patient-related data under HIPAA and client agreements, and set the rules for which data and AI tools may be used for which task.
- Hire and develop data engineers, and plan the team's roadmap with Clinical Operations, Biostatistics and Regulatory Affairs.
Qualifications
- Bachelor's degree in computer science, engineering, statistics or a related field; a master's degree is an advantage.
- At least 8 years of data engineering experience, including at least 3 years in clinical research, diagnostics, medical devices or another regulated health setting, and at least 2 years leading engineers.
- Strong SQL and Python, and hands-on experience building data pipelines and warehouses on a major cloud platform.
- Working knowledge of clinical data flows, electronic data capture, and the validation and audit-trail requirements of regulated systems.
- Experience supporting machine learning work with reproducible datasets, experiment tracking and controlled evaluation.
Preferred experience
- Experience with medical imaging or image-based machine learning data.
- Familiarity with FDA guidance on software as a medical device and AI-enabled device software functions, and with IEC 62304.
- Experience with CDISC SDTM and ADaM datasets for regulatory submissions.
- Experience with diagnostic accuracy studies and measures such as sensitivity, specificity and agreement.
About Hopkins MedTech Compliance
Hopkins MedTech Compliance is an independent contract research organization (CRO) for medical devices and in vitro diagnostics (IVD). Operated by Hopkins MedTech Group LLC, a New Jersey limited liability company, we plan and run clinical performance studies and prepare the regulatory submissions that follow, for the United States (FDA) and the European Union.
How to apply
Send your CV and a short note naming this role (HMC-FT-03) to info@hopkinsmedtech.com, or use the contact page.
