Clinical Operations

• Lead clinical trial planning and execution across the full study lifecycle, including study start-up and ongoing study management
• Prepare and manage study documentation, including TMF and ISF
• Monitor project timelines and ensure adherence to the Project Plan and study objectives
• Own project financial management, including project budgets, budget control and reporting to the functional unit head
• Lead regulatory submissions to the FDA, IRBs and other relevant authorities, including INDs, CTAs, amendments and safety reports
• Coordinate cross-functional and international project teams across the U.S. and Germany
• Supervise and coordinate subcontractor activities
• Oversee clinical trial technology and digital platforms, including ePRO, eCOA and eCRF
• Co-manage supporting IT services and ensure solutions function effectively for U.S. clients and participants
• Collaborate with technical teams to resolve issues, implement updates and improve workflows
• Develop and implement processes, SOPs, work instructions and standardized documentation
• Coordinate clinical trial sites, including site communication, training, document shipment and tracking, and payment processing
• Travel may be necessary within a project

Clinical Project Manager – Clinical Research, IT

• Develop, own, and continuously refine engagement strategies for assigned clinical programs and studies
• Establish and lead cross-functional, program/study-specific Engagement Teams
• Develop and drive engagement plans across the full study lifecycle, from protocol concept and feasibility through execution and close-out
• Serve as the strategic voice of clinical sites within CSL
• Translate site feedback, operational data, and external intelligence into recommendations for feasibility, site selection, recruitment, retention, study execution, and site experience
• Identify risks, barriers, and opportunities early and challenge assumptions and processes
• Align stakeholders across functions and geographies and embed site engagement priorities into study decisions
• Coordinate consistent site engagement across CSL functions
• Identify opportunities to simplify processes, reduce site burden, improve communication, quality, efficiency, timelines, and cost
• Capture and share lessons learned and site insights
• Build and maintain relationships with institutions, investigators, and partner sites
• Understand investigator and site needs, capabilities, challenges, and expectations
• Engage proactively with sites regarding operational trends, barriers, opportunities, and external developments
• Establish feedback mechanisms and communication pathways between sites and CSL
• Champion the site perspective while balancing investigator, study team, patient, and business needs

Associate Director, Clinical Operations – Site Engagement Lead

• Partner with Primary Care Organization and CenterWell leadership to shape strategic direction and translate strategy into measurable business results
• Solve complex business problems and evaluate strategic opportunities
• Lead structured problem-solving and hypothesis-driven analyses using financial modeling, qualitative insights, and market research
• Summarize complex information into executive-ready presentations and recommendations for leadership and Board decision-making
• Evaluate strategic opportunities, feasibility, risks, and implementation considerations
• Own priority workstreams, including workplans, interdependencies, milestones, stakeholder alignment, and risk identification
• Facilitate cross-functional engagement through working sessions and stakeholder alignment activities
• Develop business cases, value analyses, KPI frameworks, and leadership updates
• Report to the Associate VP, PCO Strategy
• Support coordinated execution across the Primary Care Organization

Clinical Operations Strategy Lead

• Develop and administer the Epic Factory AI Program
• Lead cross-application strategic initiatives under the AVP of Clinical Applications for Strategic Projects & AI
• Work with IT leadership and business units to develop business cases and requirements for technology-related business problems
• Support business relationship management, business strategy and planning, and portfolio/demand management
• Maintain productive relationships across IT and business functions
• Articulate business value and strategy and coordinate across IT to achieve operational excellence
• Research industry practices and performance metrics
• Coordinate and monitor project activities and provide technical direction to project teams
• Analyze project portfolio initiatives and identify measurable outcomes
• Implement processes and tools to measure project benefits
• Mentor and coach IT staff on workflows and functionality for new and enhanced systems and processes
• Participate in analyst technical skill development and provide input to performance reviews and development objectives
• Create business process mappings showing system and workflow interdependencies
• Support risk mitigation, communication plans, implementation strategies, work plans, and scope management

IT Program Manager – Clinical Applications, Strategic Initiatives, AI

• Design, develop, build, implement, and integrate clinical program workflows and system designs
• Develop and manage clinical programs through data analysis, project planning, workflow design, system design, tracking, and implementation
• Support continuous improvement through Plan-Do-Study-Act (PDSA) reviews
• Monitor and track model impact requests, workflows, product performance, and program performance
• Collaborate with Training and Auditing teams on program materials, system workflows, assessments, system design, and updates
• Collaborate with Clinical Operations Clinical Systems Configuration teams on program design, system build, and reporting capabilities
• Support new business activities, including RFP responses and clinical model implementation
• Collaborate with Informatics, Analytics, and Reporting teams to align process changes with metrics and reporting standards
• Work with executives, stakeholders, and leaders across markets and products to align programs with strategy, regulatory requirements, and resourcing
• Provide regular reporting and ongoing communications to senior management, stakeholders, and executive sponsors
• Represent the clinical operating model in intake, governance, and prioritization processes
• Monitor outcomes to identify opportunities for improvement in program design and application
• Perform other duties as requested

Clinical Operations Program Manager – Operating Model

• Serve as the sponsor operational lead for assigned clinical trials
• Lead cross-functional study teams across Clinical Operations, Medical, Regulatory, Data Management, Biostatistics, Safety, Clinical Supply, Quality, Legal, Finance, and external partners
• Provide sponsor oversight of CROs, vendors, and external partners
• Develop and manage study plans, timelines, risk-management plans, communication plans, monitoring oversight plans, recruitment plans, and other operational plans
• Oversee country and site feasibility, site selection, study start-up, regulatory and ethics submissions, site activation, enrollment readiness, and site performance
• Monitor milestones, enrollment targets, budgets, forecasts, risks, and deliverables; develop mitigation strategies and escalate issues
• Manage study budgets, forecasts, purchase orders, invoices, accruals, change orders, and vendor/site financial oversight
• Develop and provide sponsor input into study documents, including protocols, informed consent forms, study manuals, monitoring plans, vendor plans, training materials, newsletters, and operational guidance
• Ensure quality oversight and inspection readiness through TMF/eTMF completeness, protocol deviation oversight, issue management, audit responses, CAPA follow-up, and compliance
• Support patient recruitment and retention strategies and remove operational barriers
• Prepare and communicate study updates, dashboards, metrics, risks, decisions, and mitigation plans
• Lead study team meetings, vendor governance meetings, risk reviews, lessons learned, and operational decision-making forums
• Represent Clinical Operations in investigator meetings, vendor meetings, conferences, audits, inspections, and governance discussions

Senior Clinical Project Manager

• Provide end-to-end Sponsor operational leadership and accountability for the clinical program across Phase 1/2 studies and the registrational Phase 3 program
• Translate clinical development strategy into an integrated global operational strategy covering sequencing, timelines, country and site strategy, enrollment, resources, vendors, budgets, systems, and dependencies
• Serve as senior Study Management representative on the cross-functional program team
• Develop and maintain integrated program plans and critical paths across studies
• Provide operational input into protocol development and study design
• Lead global feasibility, trial optimization, enrollment modeling, and country/site placement strategy
• Lead global site start-up and activation strategy and manage critical paths
• Establish start-up metrics, dashboards, predictive indicators, and a single source of truth for program execution
• Provide hands-on Sponsor oversight of Phase 1 and Phase 2 studies
• Lead operational readiness for the registrational Phase 3 program
• Identify, assess, escalate, and mitigate operational risks
• Establish CRO governance and hold CROs and vendors accountable for delivery, quality, timelines, enrollment, start-up, issue resolution, and budgets
• Lead CRO/vendor selection, scope development, contracting strategy, change-order management, and performance management
• Build relationships with investigators and sites and incorporate site insights into operational strategy
• Apply AI, advanced analytics, automation, digital technologies, and AI-enabled workflows to improve trial planning, execution, forecasting, oversight, and decision-making
• Partner with Clinical Development, Regulatory, Biometrics/Data Management, Safety, Quality, Technical Operations, Development Services, technology, and data science teams
• Provide decision-oriented program updates to senior leadership
• Ensure inspection readiness, GCP compliance, Sponsor oversight, and documentation of decisions, risks, escalations, and governance
• Mentor Study Management team members and build program-management capabilities within Global Clinical Operations

Vice President – Clinical Operations

• Lead key workstreams and large-scale client engagements related to clinical development and clinical operations
• Advise clients on clinical trial execution, site management strategies, patient recruitment, and study performance optimization
• Develop recommendations to improve clinical development operating models, processes, and organizational effectiveness
• Manage multidisciplinary teams and ensure delivery of high-quality client outcomes
• Build and maintain relationships with senior client stakeholders
• Support business development activities and contribute to proposal development and thought leadership
• Stay abreast of industry trends, evolving regulatory requirements, and emerging technologies impacting clinical development
• Coach, mentor, and develop team members
• Help pharmaceutical, biotechnology, medical device, and emerging biopharma organizations optimize clinical development and trial operations

Senior Manager – Clinical Operations, Life Sciences

• Own network quality and clinician curation, including decisions about network admission and removal
• Run regular coaching, course-correction, and escalation conversations with clinicians and supervisors
• Review and act on clinical quality concerns and complaints
• Design processes for raising, reviewing, and resolving clinical concerns
• Own crisis response and safety protocols, including suicidal ideation, higher levels of care, mandated reporting, incident intake, and investigation
• Handle escalations from supervisors and clinicians
• Create protocols when clinical questions reveal gaps
• Own day-to-day clinical protocols covering discharge, disengagement, documentation standards, chart audits, measurement-based care, and treatment planning
• Apply clinical and regulatory knowledge when working with payers or auditors
• Carry a small caseload on Marble's platform
• Work closely with the co-founders, medical director, head of operations, and care quality product engineering team

Clinical Operations Lead

• Lead large, complex, and strategically important programs spanning multiple business areas and workstreams
• Lead through influence rather than positional authority, building alignment, driving accountability, and securing commitment from cross-functional teams and stakeholders
• Drive program planning, execution, governance, and delivery
• Manage program-level risks, issues, dependencies, and resource constraints across multiple initiatives
• Partner with executive and senior leaders to align priorities, facilitate decision-making, and maintain stakeholder engagement
• Develop and present executive-level status updates, dashboards, and recommendations
• Coordinate cross-functional teams to integrate people, processes, technology, and operational readiness activities
• Establish and maintain program governance, escalation pathways, and delivery standards aligned with PMO best practices
• Align strategic objectives, program planning, and execution to deliver measurable business value and targeted outcomes
• Mentor and coach project managers to strengthen delivery capabilities, consistency, and PMO maturity
• Identify and implement continuous-improvement solutions
• Support portfolio planning and prioritization to align resources with high-value initiatives
• Participate in pre-recorded Voice Interview and/or SMS Text Messaging interview if selected
• Occasionally travel to Humana offices for training or meetings

Clinical Operations jobs in United States