Clinical Operations

• Develop, implement, maintain, and evaluate data-driven quality assessment and performance improvement programs
• Promote and support Continuous Quality Improvement principles, methods, and tools to improve processes and patient outcomes
• Oversee clinical quality across in-center, inpatient, home hemodialysis, and home peritoneal dialysis modalities
• Facilitate implementation of FKC Quality programs and initiatives into facility standard operating procedures
• Serve as a clinical quality subject matter expert and identify improvement opportunities to meet CMS Conditions for Coverage and FMS quality requirements
• Manage execution of quality initiatives, interventions, and standardized education materials with facility RNs
• Provide nursing and clinical guidance to facility RNs on quality, patient satisfaction, teamwork, unit culture, and employee satisfaction
• Collaborate with Clinical Quality leadership, Education, Clinical Services, Regulatory, Compliance, and other stakeholders
• Mentor and train staff to collect, trend, and analyze data to improve patient-centered care and outcomes
• Apply evidence-based practices, clinical pathways, policies, procedures, algorithms, and standing orders to address quality barriers
• Use tools, resources, and informatics technology to focus on targeted patient populations
• Review facility QAPI documentation, attend QAPI meetings, and evaluate facility QAPI and CQI effectiveness
• Review QAI activities, calendars, tools, and electronic applications
• Attend regional, area, facility, and team meetings
• Identify risk areas, assist with root cause analyses and action plans, and provide recommendations to management
• Execute education programs using adult education principles
• Maintain effective relationships and communication with patients, staff, physicians, field management, payers, and other customers
• Assist with projects and perform other related duties as assigned

Strategic Clinical Quality Manager

• Support onboarding and ramp-up for the Clinical Study Operations team
• Translate strategic priorities into a roadmap for the area, including initiative sequencing, process investment, and team growth
• Oversee ClinOps execution across feasibility, site start-up, enrollment, monitoring, and close-out
• Escalate risks and blockers to leadership with clear tradeoffs and options
• Own ClinOps KPIs and goals, track progress in Asana, and report to leadership and cross-functional partners
• Make issue-classification and escalation decisions, including complaint versus technical-issue calls and device reconciliation/invoicing decisions
• Lead domain-level ClinOps initiatives such as process standardization, tooling rollouts, and dashboard/reporting improvements
• Maintain and improve ClinOps SOPs, work instructions, and CTMS practices
• Represent ClinOps in BD conversations, feasibility discussions, and Investigator Meetings
• Manage working relationships with sponsors and CRO intermediaries; represent Beacon directly when escalated decisions require alignment or sign-off
• Partner with Product, Engineering, Life Science, Data Science, and BD to keep trials on track and compliant

Manager, Clinical Study Operations

• Lead and direct execution of multiple global Phase 2/3 studies aligned with enrollment objectives and timelines
• Manage trial managers and CTAs and provide expert counsel for issue resolution
• Provide Clinical Operations leadership under the Executive Director of Clinical Development Operations
• Contribute to Clinical Development Plans and associated operational strategy
• Collaborate with Clinical Study Teams to develop and implement study plans
• Oversee execution of assigned clinical programs, focusing on quality, budget, and timelines
• Oversee Strategic Partners and other vendors to meet ICH-GCP obligations and business objectives
• Track KPIs for study milestones and communicate program status, costs, and issues to senior management
• Assist in authoring key regulatory documents and align clinical program deliverables with submission requirements and regulatory expectations
• Collaborate with medical, regulatory affairs, data management, biostatistics, and medical affairs teams
• Share learnings and best practices to enable process improvements
• Monitor industry trends, emerging technologies, and innovative recruitment solutions
• Perform other business needs identified by the direct line manager

Director, Clinical Operations

• Develop, implement, maintain and evaluate data-driven quality assessment and performance improvement programs
• Promote Continuous Quality Improvement principles, methods and tools to improve processes and patient outcomes
• Oversee clinical quality across in-center, home hemodialysis and home peritoneal dialysis modalities
• Monitor data and information, prioritize improvement areas, identify root causes, and develop, implement, evaluate and revise improvement plans
• Facilitate implementation of FKC Quality programs and initiatives into facility standard operating procedures
• Serve as a clinical quality subject matter expert and identify opportunities to meet CMS Conditions for Coverage and FMS quality requirements
• Manage execution of quality initiatives, interventions and standardized education materials with facility RNs
• Provide nursing and clinical guidance to facility RNs regarding quality, patient satisfaction, teamwork, unit culture and employee satisfaction
• Collaborate with Clinical Quality, Education, Clinical Services, Regulatory and Compliance stakeholders
• Mentor and train staff to collect, trend and analyze data to improve patient-centered care and outcomes
• Apply evidence-based practices, clinical pathways, algorithms, standing orders and policies to address quality-improvement barriers
• Use tools, resources and informatics technology to focus on targeted patient populations
• Mentor facilities in identifying, testing, adopting and implementing effective quality-improvement practices
• Provide guidance and subject matter expertise on quality policies, standards, tools and electronic applications
• Review facility QAPI documentation, QAI activities, calendars, tools and electronic applications
• Attend QAPI, regional, area, facility and team meetings
• Identify risk areas, assist with root-cause analyses and action-plan development and evaluation
• Provide written or verbal recommendations to facility and area management
• Execute education programs using adult education principles
• Maintain timely communication and working relationships with patients, staff, physicians, management, payers and other customers
• Assist with assigned projects and perform other related duties