The Position

The Clinical Operations Manager (COM) manages multiple Phase 1-4 clinical trials with minimal supervision in order to achieve study deliverables and milestones.

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
• Track, report, and present study metrics, progress reports, and timelines
• Manage adherence to GCP and local regulations governing study execution
• Proactively identify and resolve study-level risks and issues
• Assist in the external service provider selection
• Oversee external service provider (eg CRO, central lab, recruitment, homecare, etc.) set-up, activation, deliverables and close-out activities
• Provide guidance, mentorship and oversight to more junior Clinical Operations staff members
• Effectively collaborate and coordinate 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
• Recommend modifications to SOPs/Work Instructions when necessary to improve compliance or efficiency

Requirements:

• Minimum 6 years in clinical research and development
• Preferred 3 years onsite monitoring/auditing/site management experience
• Preferred 2 years with responsibility for managing key clinical study deliverables
• Preferred 2 years managing external clinical service providers
• Minimum 1 year in the role of managing a Phase 1-3 interventional trial
• Advance knowledge of ICH-GCP
• Excellent interpersonal, verbal and written communication skills
• Consistently display a high level of professionalism, diplomacy and respect for others
• Must be able to work collaboratively and professionally with team members and external service providers such as CROs
• Strong organizational skills and attention to detail
• Ability to multi-task and prioritize appropriately
• Proficient in clinical project management tools and techniques
• Ability to think critically and problem-solve effectively
• Accurate and timely in performance of duties
• Understands need for confidentiality in all aspects of position
• Proficient software skills (Outlook, Word, Excel, Power Point, MS Project)
• Proficient in Veeva eTMF and Medidata EDC

Preferred: 

• 4-year college degree preferred