Overview:
Monte Rosa Therapeutics is seeking a Clinical Systems Specialist to join our IT team as the technical bridge between Clinical Operations, Clinical Data Science, and Biomarkers, and the systems that run underneath them. This hands-on, builder-oriented role owns support of our clinical operations systems (EDC, IRT/RTSM, eTMF) and, just as importantly, builds the data pipelines and integrations that move information reliably between those systems and our internal data platform — so Clinical Data Scientists and the Biomarkers team spend their time on analysis, not wrangling data. Automation and reducing toil are core to the role, and you'll work closely with the rest of the IT team on thoughtful application of our technology stack to support the business.
Responsibilities
Clinical & Clinical Operations Systems Support:- Administer and support core clinical operations systems — EDC (e.g., Medidata Rave), IRT/RTSM (e.g., Suvoda), eTMF, and CTMS — including access, study builds, and day-to-day troubleshooting.
- Serve as the IT point of contact for clinical vendor and CRO systems, coordinating access and data exchange with vendor technical teams.
- Maintain documentation of clinical system architecture, data flows, and access controls to support audit readiness (21 CFR Part 11, data integrity).Data Pipelines & Systems Integration
- Design, build, and maintain data pipelines moving clinical, operational, and biomarker/assay data from EDC, IRT, and CRO/lab vendor sources into our data platform.
- Build and support integrations between clinical systems and downstream consumers — Clinical Data Science, Biomarkers, and reporting tools.
- Own ingestion and harmonization of CRO/central-lab assay data into consistent, reusable datasets.
- Monitor pipeline health and data freshness, proactively resolving failures before they affect downstream analysis. Automation & Toil Reduction
- Replace recurring manual work — CRO file drops, reconciliation, ad hoc extracts — with scripted, scheduled, or event-driven automation.
- Build lightweight tooling (Python, SQL, serverless/Lambda) that gives Clinical Data Science and Biomarkers self-service access to clean, current data.
- Apply automation and AI/agentic tooling to reduce toil in clinical data operations, and document reusable solutions rather than one-off fixes. Cross-Functional IT Collaboration & Support
- Work closely with the broader IT team on shared priorities — vendor access reviews, vulnerability remediation, and enterprise support.
- Represent IT in cross-functional discussions with Clinical Operations, Clinical Data Science, and Biomarkers.
Qualifications:
Required 3+ years of experience supporting clinical or clinical operations systems (EDC such as Medidata Rave/Veeva, IRT/RTSM, eTMF, CTMS) in a biotech, pharma, or CRO environment. Hands-on experience building data pipelines or integrations between clinical/vendor systems and a cloud data platform (AWS S3, Athena, Glue, Lambda or equivalent).Working proficiency in SQL and at least one scripting/automation language (Python preferred).Understanding of clinical data structures and standards (CDISC SDTM/ODM, EDC data models).Genuine orientation toward automation and reducing manual toil, with a track record of replacing repetitive processes with scripts or pipelines. Working knowledge of data privacy and integrity requirements relevant to clinical data (21 CFR Part 11, GxP data handling).Preferred Experience with biomarker/translational data platforms or CRO assay data harmonization (e.g., QuartzBio, TetraScience) and/or CDISC tooling such as Certara Pinnacle 21.Familiarity with workflow orchestration (AWS Step Functions, etc) and infrastructure-as-code for productionizing pipelines. Exposure to ELN/LIMS platforms (e.g., Benchling) and familiarity with data lake/analytical warehouses. A bachelor's degree in a technical, life sciences, or clinical data field, or equivalent hands-on experience. Job SummaryID: 2026-1231
Category: Information Technology
Position Type: Regular Full-TimeMin: USD $85,000.00/Yr. Max: USD $105,000.00/Yr.
