Senior Study Manager – IBD

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🔥 7 minutes ago

🌐 Switzerland, United Kingdom – Remote

🇨🇭 Switzerland – Remote 🇬🇧 United Kingdom – Remote

⏰ Full Time

🟠 Senior

👔 Manager

👻 Ghost score 12%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Numab Therapeutics AG

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2011

🧬 Biotechnology

💊 Pharmaceuticals

💰 $54.9M Series C - Numab on 2025-01

Biotechnology • Pharmaceuticals

Numab Therapeutics AG is a Swiss biotechnology company based in Horgen that discovers and develops next-generation multispecific antibody-based therapeutics for immunology and immuno-oncology. Numab uses proprietary discovery and engineering platforms (λ-Cap™ and MATCH™) to design plug-and-play multispecific molecules intended to improve potency, stability, pharmacokinetics, duration of effect, and safety versus first-generation antibodies. The company advances an in-house pipeline and collaborates with pharmaceutical partners (e. g. , Boehringer Ingelheim, Kaken Pharmaceutical) to co-develop and license multispecific antibody candidates for diseases including inflammatory bowel disease and retinal and tumor indications.

📋 Description

• Lead operational delivery of assigned Phase I studies from start-up through closeout and reconciliation • Act as Numab’s day-to-day operational counterpart to the CRO, tracking commitments and resolving study issues • Maintain integrated study plans, milestones, risk and issue logs, and decision records • Review CRO deliverables and ensure actions are completed • Coordinate readiness for dose-escalation and safety review meetings • Prepare decision-ready updates for the Head of Clinical Operations and cross-functional stakeholders • Manage study scope, timelines, critical-path dependencies, change control, budgets and vendor performance • Implement protocol amendments and study expansions • Manage key site relationships, feasibility, site selection, activation readiness and recruitment performance • Travel to investigator sites when needed • Support EDC, eTMF, IRT/RTSM and other clinical-system setup and use • Oversee site data-entry quality, query resolution and data integrity • Coordinate investigational-product and clinical-supply readiness, including forecasting, batch release, shipment and reconciliation • Coordinate PK, ADA/immunogenicity, biomarker and other sample strategies • Coordinate delivery across CROs, laboratories, bioanalytical partners, IRT/RTSM and other vendors • Ensure compliance with ICH GCP, applicable regulations, protocols, SOPs and quality expectations • Support audit/inspection readiness and CAPA follow-up • Partner with Clinical, Regulatory, CMC, Biometrics, Safety and Quality colleagues

🎯 Requirements

• Substantial clinical operations experience, including direct ownership of early phase clinical study delivery • Experience of Phase I healthy volunteer and dose-escalation studies is essential • Strong practical understanding of first-in-human studies, including start-up, participant safety, complex eligibility assessment, dose-escalation decision support and intensive site/CRO coordination • Experience working in biotech is highly desired • Demonstrable experience managing CROs and clinical sites • Experience in country and site feasibility, activation and participant recruitment, including specialised Phase I units and multi-site patient studies • Experience supporting studies through significant protocol amendments, cohort expansion or transition from healthy volunteers into patient populations • Working knowledge of clinical data capture and trial systems, including EDC set-up, data-entry quality and operational data review • Experience in inflammatory bowel disease, immunology or gastroenterology is highly desirable