Senior Study Manager – IBD

• 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

• 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