Clinical Operations

• Working on the development, creation, maintenance, and management of the client-specific clinical benefits, formularies, and utilization management edits.
• Supporting the clinical and benefit teams in all clinical benefit and formulary set-up/coding efforts required to meet client-specific needs and requirements.
• Performing tasks associated with clinical benefit and formulary documentation and reporting needs across all lines of business offered by the client.
• Ensuring all relevant activities are at highest level of clinical appropriateness, accuracy, clinical consistency, and in full compliance with client requirements and applicable rules and regulations.

Clinical Pharmacist, Clinical Account Operations

• Lead and manage global Phase I virology clinical trials from study start-up through closeout with minimal supervision
• Drive overall study execution, timelines, deliverables, risks, budgets, and operational performance
• Provide oversight and accountability for CROs, vendors, and cross-functional partners to ensure high-quality study execution
• Build strong collaborative relationships with Clinical Operations, Data Management, Regulatory, Medical, Clinical Supply, Biometrics, and other stakeholders
• Lead study team meetings by establishing clear agendas, facilitating productive discussions, documenting key decisions, and ensuring timely completion of action items
• Proactively identify operational risks, develop mitigation strategies, and drive issue resolution before timelines or quality are impacted
• Guide study teams through key transitions across the clinical trial lifecycle while ensuring seamless operational execution
• Maintain oversight of study documentation, trial metrics, operational deliverables, and inspection readiness activities
• Ensure compliance with GCP, SOPs, regulatory requirements, and sponsor expectations
• Foster accountability across study teams while creating an environment of collaboration, transparency, and shared ownership
• Contribute to process improvements and operational best practices that enhance study execution and team performance

Clinical Project Manager II – Virology, Phase I

• Line management of Clinical Operations staff, responsibilities including interviewing and selection, termination, professional development, performance appraisals, and employee counselling
• Participate in managing the resource availability for the assigned staff, providing support that projects are suitably resourced
• Provide expert operational oversight and guidance to support prioritization of activities
• Assist in recruiting new staff, including participation in interview process and new hire on boarding
• Ensure quality and adherence to Standard Operating Procedures/Work Instructions (SOP/WIs) and compliance with federal and local guidelines and ICH GCP
• Work closely within appropriate business unit/region to ensure staff performance on studies
• Organize and chair clinical staff meetings at regular intervals
• Facilitate and support project and team/country reviews with Clinical Operations staff

Manager, Clinical Operations – CRA Line Management, CRA Monitoring Experience Required

• Lead Biomarker Study Operations
• Oversee biomarker and bioanalytical activities across Sponsor and Collaborative programs
• Serve as the operational point of contact for all biomarker-related processes
• Work closely with clinical study teams (Phases 1–4) to integrate biomarker strategies into broader clinical development plans
• Plan and manage the collection, tracking, and analysis of biological specimens
• Advise study teams on best practices for sample management and logistics
• Lead cross-functional teams through the full clinical trial lifecycle, from start-up to closeout
• Ensure studies stay on track with respect to timelines, budget, scope, and quality
• Act as the main liaison between the sponsor and study partners
• Monitor and manage project financials, ensuring fiscal responsibility
• Proactively identify and resolve operational issues and risks
• Maintain high-quality documentation, including Trial Master File (TMF) accuracy and completeness
• Keep study systems and databases current and audit-ready
• Prepare project reports and updates for sponsors and internal stakeholders
• Plan and facilitate internal and external meetings
• Support inspection readiness and regulatory compliance throughout the project

Clinical Project Manager II – Biomarker Study Management

• The Clinical Site Manager is responsible for designing, planning, coordinating and conducting all activities involved in initiating, monitoring, and completing clinical research studies in the clinical study sites and delivering as appropriate other data generation methodologies.
• Act as primary contact and clinical trial expert for assigned study site personnel for execution of the study - including training and coordinating certification of study site personnel and providing technical assistance, as necessary.
• Perform site assessments/site qualification visits in the site selection decision process.
• May participate in and ensure site activation (contracting, IRB/EC/Health Authority approvals are, etc.) are properly obtained, maintained and meet regulatory requirements in collaboration with relevant RDS Functions prior to initiation of the investigational site.
• Develop key study site documents (e.g. Study Monitoring Plan, informed consent documents, source documents, patient instruction guides and case report forms, etc.) and contribute technical expertise in the review of study protocols, data management plans, reports and manuscript, etc.
• Collaborate cross-functionally with R&D, Field Service, Study Management, Biometrics, etc. to deliver best solutions.
• Deliver all data generation/validation and site monitoring activities including end-to-end site visits per relevant regulations and processes.
• May participate in the oversight of CRO delivery of Site Management activities, including training of CRO CRAs. This includes escalation of any issues.
• May work with international investigators and key customers as well.
• May coach colleagues and help others develop expertise/skills
• Accountable for site-level budget of assigned sites
• Work independently and is autonomous

Clinical Operations jobs in Arizona

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Clinical Pharmacist, Clinical Account Operations

Clinical Project Manager II – Virology, Phase I

Manager, Clinical Operations – CRA Line Management, CRA Monitoring Experience Required

Clinical Project Manager II – Biomarker Study Management

Clinical Site Manager