Senior Study Manager – IBD

This is a fully remote position, open to applicants in Switzerland, +1 more country.

📋 Description

• Oversee the operational execution of designated Phase I studies from initiation to closeout and reconciliation.

• Serve as Numab’s primary operational liaison to the CRO, monitoring commitments and addressing study-related issues.

• Maintain comprehensive study plans, milestones, risk and issue logs, and documentation of decisions.

• Evaluate CRO deliverables and ensure that all necessary actions are implemented.

• Organize preparations for dose-escalation and safety review meetings.

• Create updates that are ready for decision-making for the Head of Clinical Operations and cross-functional stakeholders.

• Oversee study scope, timelines, critical-path dependencies, change control, budgets, and vendor performance.

• Implement protocol amendments and facilitate study expansions.

• Manage essential site relationships, feasibility assessments, site selection, activation readiness, and recruitment performance.

• Travel to investigator sites as necessary.

• Provide support for EDC, eTMF, IRT/RTSM, and other clinical-system setup and utilization.

• Supervise the quality of site data entry, query resolution, and data integrity.

• Coordinate the readiness of investigational products and clinical supplies, including forecasting, batch release, shipment, and reconciliation.

• Coordinate strategies for PK, ADA/immunogenicity, biomarkers, and other sample analysis.

• Ensure effective delivery across CROs, laboratories, bioanalytical partners, IRT/RTSM, and other vendors.

• Guarantee compliance with ICH GCP, relevant regulations, protocols, SOPs, and quality standards.

• Assist in audit/inspection readiness and follow-up on CAPA.

• Collaborate with colleagues in Clinical, Regulatory, CMC, Biometrics, Safety, and Quality.

⛳️ Requirements

• Significant clinical operations experience, including direct responsibility for the delivery of early-phase clinical studies.

• Essential experience with Phase I healthy volunteer and dose-escalation studies.

• Strong practical knowledge of first-in-human studies, which includes start-up, participant safety, complex eligibility evaluations, dose-escalation decision support, and intensive site/CRO coordination.

• Experience in the biotech sector is highly preferred.

• Proven experience managing CROs and clinical sites.

• Experience in country and site feasibility, activation, and participant recruitment, particularly in specialized Phase I units and multi-site patient studies.

• Experience supporting studies through significant protocol amendments, cohort expansions, or transitions from healthy volunteers to patient populations.

• Familiarity with clinical data capture and trial systems, encompassing EDC setup, data entry quality, and operational data review.

• Experience in inflammatory bowel disease, immunology, or gastroenterology is highly desirable.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance.

• Flexible working hours and the possibility of remote work.

• Opportunities for professional development and training.

• A supportive and collaborative work environment.