Clinical Systems Specialist, IT

Monte Rosa Therapeutics, Inc; Boston (MA); On-site; USD 110,000 - 145,000; Full time

Job summary

Monte Rosa Therapeutics, Inc. is seeking a Clinical Systems Specialist to bridge Clinical Operations, Data Science, and Biomarkers with hands-on support for EDC, IRT/RTSM, eTMF, and CTMS. The role builds data pipelines, integrates systems with the data platform, and focuses on automation to reduce toil across study data workflows.

The candidate will work with IT to ensure data integrity, security, and audit readiness while enabling scientists to focus on analysis rather than data wrangling.

Qualifications

• 3+ years of experience supporting clinical operations systems (EDC, IRT/RTSM, eTMF, CTMS).
• Hands-on experience building data pipelines or integrations between clinical/vendor systems and a cloud data platform.
• Proficient in SQL and at least one scripting language (Python preferred).
• Understanding of clinical data structures and standards (CDISC SDTM/ODM).
• Commitment to automation and reducing manual toil.

Responsibilities

• Administer and support core clinical operations systems (EDC, IRT/RTSM, eTMF, CTMS) including access, study builds, and troubleshooting.
• Serve as IT point of contact for clinical vendor/CRO systems and coordinate data exchange.
• Design, build, and maintain data pipelines moving data into the data platform and support integrations to downstream tools.

Skills

SQL

Python

Cloud data platforms

Automation

Data integration

CDISC SDTM/ODM

Education

Bachelor's degree in a technical field

Tools

Medidata Rave

Suvoda

eTMF

CTMS

AWS

Job description

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.