Clinical Systems Lead - Hybrid, Data & Compliance

Rapport Therapeutics

Boston (MA)

Hybrid

USD 120,000 - 145,000

Full time

45 hours ago

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Benefits offered by this job

Unlimited PTO

Lifestyle spending account

Commuting reimbursement

Great benefits package

Job summary

Rapport Therapeutics in Boston is seeking a Clinical Systems Manager to oversee the implementation, maintenance, and security of clinical information systems (EDC, IRT, data warehousing) to support compliant clinical research. This role partners with Data Management, Biostatistics, and IT.

You will lead system deployment, vendor management, data interfaces (HL7/FHIR), and ensure HIPAA, 21 CFR Part 11 compliance.

Qualifications

Bachelor's degree in CS, IS, nursing, life sciences, or related field.
4–7 years in healthcare, clinical development, or IT data management; 2+ years in leadership role.
Proficiency with EHR systems, SQL, SAS, cloud environments (AWS/GCP); CDASH/SDTM data standards.

Responsibilities

System Administration: deploy, operate, upgrades, and configure clinical platforms.
Cross-Functional Liaison between clinical end-users and IT/vendors.
Integration & Data Flow: manage HL7/FHIR interfaces and data movement.
Compliance & Validation with HIPAA, GCP, 21 CFR Part 11.
User Training & Support: write SOPs and guide staff on system usage.
Vendor & Project Management: oversee third-party software and milestones.
Partner across Data Management, Biostatistics, Programming, Clinical Ops, Finance, and Clinical Development.