Senior Manager, Clinical Operations

The Position

The Senior Manager, Clinical Operations manages multiple Phase 1-4 clinical trials with minimal supervision to achieve study deliverables and milestones.  Based in New Zealand this position will support all of Arrowhead’s studies in the region. 

Responsibilities

• Serve as the main point of contact and coordination for assigned trials
• Accountable for the overall completeness and inspection readiness of the TMF for assigned studies.
• Develop, manage, review and track study budgets and contracts
• Review and approve external service provider change orders, contract amendments, and invoices
• Provide accurate study drug utilization forecasts and periodic updates for assigned studies
• Review and approve study drug labeling and procurement of ancillary supplies
• Develop and approve Pharmacy Manual and associated study-specific templates and forms
• Support IRT system set-up, testing, and on-time activation
• Accountable for site and study-level IMP accountability and final reconciliation
• Oversee investigator identification, feasibility, selection and site activation
• Oversee management of investigative site issue escalations, performance and compliance issues
• Develop, review, approve and deliver site-level training and study level updates to investigative sites
• Oversee investigative site close-out activities
• Oversee execution of assigned studies, manage study timelines, operational plans, and CRO performance to achieve deliverables on time, on budget and with acceptable quality
• Oversee the development and finalization of clinical operational plans (eg Monitoring Plan, TMF Plan, Protocol Deviation Plan) case report forms, informed consent documents, study specific forms, study training and reference materials
• Contribute to the development of protocols, amendments, clinical study/periodic reports and investigator brochures
• Provide updates on study/site status as needed to management and to ensure timely updates are reflected on ClinicalTrials.gov and equivalent public trial registries
• Manage adherence to GCP and local regulations governing study execution
• Track, report and present study metrics, progress reports, and timelines
• Proactively identify and resolve trial-level risks and issues
• Assist in the external service provider selection
• Oversee external service provider (e.g. CRO, central lab, recruitment, homecare, etc.) set-up, activation, deliverables and close-out activities
• Support TA Management in program level projects or responsibilities as assigned
• Contribute to TA/Program-level documents and reports
• May serve as primary point of contact/TA representative to internal departments as assigned
• Provide guidance, mentorship and oversight to more junior Clinical Operations staff members
• Effectively collaborates and coordinates with external service providers and Arrowhead functional groups and departments such as Safety, Legal, Finance, Program Management, Medical Writing, Clinical Pharmacology, and Regulatory to achieve study deliverables
• Support the conduct and resolution of routine and focused study audits and inspections
• Participate in and represent Clinical Operations in cross-functional initiatives, as assigned by management, and may act on behalf of department when designated
• Maintain compliance with assigned procedures, guidelines, study plans and applicable regulatory requirements
• Develop, author, or own SOP/Work Instructions, forms or templates

Requirements:

• 8 years in clinical research and development
• 1 year in the role of managing a Phase 1-3 interventional trial
• Advance knowledge of ICH-GCP

Preferred: 

• 3 years of onsite monitoring/auditing/site management experience
• 3 years with responsibility for managing key clinical study deliverables
• 3 years managing external clinical service providers