Senior Study Manager - IBD (Fully Remote)

Numab Therapeutics AG; United States; Remote; USD 140,000 - 230,000; Full time

Job summary

Numab Therapeutics AG in the United States is seeking a lead professional to drive Phase I study delivery from startup through close-out, partnering with CROs to ensure timelines and quality.

You will own site readiness, recruitment metrics, and the oversight of data systems like EDC, eTMF, and IRT/RTSM, ensuring data integrity and compliant operations.

This role requires strong CRO relationships, GCP expertise, and the ability to mitigate risks and make timely decisions.

Qualifications

• Experience in early-phase clinical operations, including PhI dose-escalation.
• Proven CRO and site management with GCP compliance.
• Ability to maintain risk plans and resolve issues promptly.

Responsibilities

• Lead Phase I study delivery from start-up to close-out.
• Maintain plans, risks, and decisions; resolve issues promptly.
• Own site readiness and recruitment performance.
• Oversee data systems (EDC, eTMF, IRT/RTSM) and ensure data integrity.

Skills

CRO management

Site management

GCP knowledge

Study leadership

Tools

EDC

eTMF

IRT/RTSM

Job description

• Lead Phase I study delivery from start-up to close-out with the CRO.
• Maintain plans, risks, and decisions, resolving issues promptly.

Site and Participant Operations:

• Own site readiness, relationships, and recruitment performance.
• Track screening metrics and implement mitigation plans.

Vendor and Quality Oversight:

• Oversee EDC, eTMF, and IRT/RTSM systems for data integrity.
• Coordinate supplies, logistics, and vendor deliverables.

Required Experience:

• Early phase clinical operations, including PhI dose-escalation.
• Strong CRO and site management with GCP.

Numab Therapeutics AG

Numab Therapeutics is a Swiss biotech developing multi-specific antibody immunotherapies. It has a broad pipeline and completed a major J&J transaction, with Series C funding of CHF 180 million.