Clinical Systems Specialist, IT

Monte Rosa Therapeutics, Inc.; Boston (MA); On-site; USD 110,000 - 160,000; Full time

Job summary

Scorpion Therapeutics is seeking a Clinical Systems Specialist to support Monte Rosa's clinical operations and data infrastructure. The role involves administering core systems (EDC, IRT/RTSM, eTMF, CTMS) and designing data pipelines to move data from vendors into the internal platform.

You will develop automation solutions using Python, SQL, and cloud tools to reduce manual tasks, ensure data integrity, and maintain GxP compliance.

Qualifications

• 3+ years supporting clinical or operational systems in biotech/pharma/CRO.
• Hands-on experience building data pipelines and integrations in cloud environments (AWS S3, Lambda, etc.).
• Proficiency in SQL and scripting languages (Python preferred).
• Understanding of clinical data standards (CDISC SDTM/ODM) and GxP regulations.
• Automation-oriented approach with a track record of reducing manual work.

Responsibilities

• Administer and troubleshoot core clinical systems (EDC, IRT/RTSM, eTMF, CTMS).
• Design and maintain data pipelines moving data from vendors into the internal platform.
• Develop automation solutions using Python, SQL, and cloud tools to reduce manual tasks.
• Ensure data integrity and compliance with GxP standards.
• Collaborate with IT, Clinical Operations, Data Science, and Biomarkers teams on system support and data integrations.

Skills

Data pipelines

Automation

Cloud integration

GxP compliance

CDISC SDTM/ODM

SQL

Python

Tools

EDC

IRT/RTSM

eTMF

CTMS

CDISC tooling

Workflow orchestration

Infrastructure as Code

Job description

Role:

Clinical Systems Specialist supporting Monte Rosa's clinical operations and data infrastructure.

Responsibilities:

• administer and troubleshoot core clinical systems (EDC, IRT/RTSM, eTMF, CTMS)
• design and maintain data pipelines moving data from vendors into the internal platform
• develop automation solutions using Python, SQL, and cloud tools to reduce manual tasks
• ensure data integrity and compliance with GxP standards
• collaborate with IT, Clinical Operations, Data Science, and Biomarkers teams on system support and data integrations

Requirements:

• 3+ years supporting clinical or operational systems in biotech/pharma/CRO
• hands-on experience building data pipelines and integrations in cloud environments (AWS S3, Lambda, etc.)
• proficiency in SQL and scripting languages (Python preferred)
• understanding of clinical data standards (CDISC SDTM/ODM) and GxP regulations
• automation-oriented approach with a track record of reducing manual work

Preferred:

experience with biomarker/assay data platforms, CDISC tooling, workflow orchestration, infrastructure-as-code, and familiarity with ELN/LIMS systems.

High-value:

• clinical operations support
• data pipeline development
• automation
• GxP compliance
• cloud integration
• biotech/pharma/CRO environment
• focus on reducing toil