Phase I Immunology Study Lead

Forbion European Acquisition Corp.; Zürich; On-site; CHF 120,000 - 180,000; Full time

Job summary

Numab Therapeutics AG in Switzerland is seeking a Senior Study Manager (Immunology) to lead Phase I studies in collaboration with CROs and clinical sites. You will drive study start-up, execution, and close-out, ensuring data quality, safety reviews, and vendor performance align with program goals.

The role requires strong CRO management, feasibility assessment, and trial systems experience, with a background in immunology or inflammatory diseases.

Qualifications

• Extensive hands-on leadership of early-phase clinical studies.
• Proven ability to manage CROs and clinical sites and hold partners to commitments.
• Experience with site activation, feasibility, recruitment tracking and risk management.
• Familiarity with EDC systems, eTMF, IRT/RTSM and data quality oversight.
• Solid understanding of ICH GCP, regulatory requirements and study governance.
• Desirable: experience in inflammatory bowel disease or immunology.

Responsibilities

• Lead Phase I study delivery from start-up to close out and reconciliation.
• Act as day-to-day operational counterpart to CRO and drive timely issue resolution.
• Develop integrated study plans, milestones, risk logs and decision records.
• Review CRO deliverables and ensure actions are owned to completion.
• Coordinate readiness for dose-escalation and safety reviews with data availability.
• Support governance updates for Head of Clinical Operations and cross-functional stakeholders.
• Forecast study scope, timelines and budgets and manage vendor performance.
• Lead protocol amendments and study expansions with internal and external teams.

Skills

Phase I study delivery

CRO leadership

Site activation & feasibility

Data systems & EDC

ICH GCP/regulatory

IBD/immunology experience

Job description

Numab Therapeutics AG in Switzerland is seeking a Senior Study Manager (Immunology) to lead Phase I studies in collaboration with CROs and clinical sites. You will drive study start-up, execution, and close-out, ensuring data quality, safety reviews, and vendor performance align with program goals.

The role requires strong CRO management, feasibility assessment, and trial systems experience, with a background in immunology or inflammatory diseases.