Clinical Operations

• Serve as designated divisional liaison with providers and ministry Care Coordination teams
• Move patients towards safe and effective discharge plans or transitions to appropriate next level of care
• Plan and develop reporting tools for sharing of information between division and ministry teams
• Foster collaborative working relationships within and beyond the Care Coordination teams
• Act as a resource and subject matter expert for both teams, providing guidance and training as needed

Clinical Program Manager, RN

• Work with study teams across a variety of functional areas to ease bandwidth strain on Coordinator responsibilities detailed below.
• Processing clinician/rater forms and documenting data via status trackers and ePortal/LMS training systems.
• Review and process submitted clinician/rater surveys and deploy applicable LMS training modules.
• Schedule 1:1 training video conferences between site raters and Cogstate Rater Services staff
• Hardware shipment scheduling and documentation management.
• Documenting real time updates to applicable status trackers, coordinating high volume email correspondence, communicating status updates to clinicians/raters, electronic records filing.
• Point of contact for clinician/rater support questions.
• Direct communication with site coordinators at clinical settings, activity and communication tracking and general support throughout study.
• Interact with CRAs for site monitoring activities.

Coordinator, Clinical Operations – West Coast

• 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

• Oversee the operations of a service site, ensuring optimal performance, safety, and customer satisfaction
• Mentor a team to uphold the organization's central beliefs and to perform in their respective functions
• Safety leadership, operational efficiency, financial performance, and customer account management
• Responsible for technical problem-solving, budget management, and ensuring optimal turbine performance

Wind Site Operations Manager

• Oversee daily staffing, scheduling, and patient care coordination workflows
• Ensure compliance with clinical protocols, documentation standards, and regulations
• Provide coaching, mentorship, and performance management for nursing staff
• Monitor team performance and implement improvements to enhance patient outcomes
• Collaborate with leadership and cross-functional teams to improve operations
• Support staff development through regular check-ins and training initiatives
• Participate in patient engagement when necessary
• Maintain a positive, inclusive, and performance-driven team culture

Clinical Operations Manager, RN – MST or PST

• Provide operational leadership for Tia’s RN function, partnering with clinical leads to ensure consistent, high-quality nursing practice across Tia’s virtual and in-person care model.
• Build and improve clinical workflows, SOPs, onboarding processes, training programs, and competency structures that support scalable RN team performance.
• Monitor staffing, scheduling coverage, queue performance, utilization, quality, and operational metrics to identify trends, resolve gaps, and improve execution.
• Support clinical quality, patient safety, regulatory compliance, and continuous improvement across RN and clinical operations workflows.
• Partner with Product, Care Coordination, Clinical Care Delivery, and Operations teams to align clinical workflows with broader company goals and care delivery needs.
• Create clear role expectations, operating rhythms, metrics, and feedback loops that support a high-ownership, high-accountability RN team.
• Spend a portion of time delivering asynchronous nursing care as needed to stay close to workflows, understand team needs, and support patient care.

Senior Clinical Operations Manager, RN

• Manage complex Phase 1, 2, 3, and 4 clinical trials as part of the Artiva Clinical Operations team.
• Demonstrate oversight of CROs and work in a quality framework that supports early and confirmatory trials
• Provide direction and leadership in CRO and vendor selection and management.
• Knowledge of regulatory start up process and planning in support of study start up
• Building, managing, and maintaining high performing clinical teams
• Contribute to strategic planning to ensure optimized clinical development plans for assigned projects.
• Inclusive of this is enrollment modelling to support scenario planning for portfolio optimization and spend/timeline analysis.
• Provide technical expertise for the development of clinical documents (protocols, monitoring plans, clinical trials report, investigator brochures, etc.) and trial conduct.
• Coordinate closely with Clinical Development, Biostatistics, Data Management, Drug Safety, Legal, Finance, Project Management and Regulatory to ensure operational excellence.
• Be responsible for, and manage, clinical research activity of Clinical Trial Managers and other staff.
• Prepare clinical research budgets and timelines.
• Manage trial budgets, spend analysis and accuracy in partnership with management and Artiva finance teams.
• Analyze and develop action plans to address issues with investigational sites, CRAs, and CROs
• Work with departmental leadership and Quality to identify and improve Artiva SOPs.
• Responsible for preparing Requests for Proposals documents (RFP’s) and soliciting bids from CROs and vendors, evaluating the submitted proposals for merit and fit, and developing a rationale for selecting a preferred vendor with the Clinical Operations Team.
• Accountable for the management of vendor agreements for outsourced activities, including vendors’ adherence to the scope of service agreements, budgets, plans and timelines, ensuring that change orders to the work scope and budgets meet clinical operations specifications.
• Responsible for driving a feasibility process leading to a collaborative evaluation and selection of clinical trial sites.
• Responsible for driving enrollment efforts to deliver the program.

Associate Director, Clinical Operations

• Provides program management and executes changes in program.
• Provides specialized behavior intervention services and program supervision to individuals with Autism Spectrum Disorder (ASD) and/or other related disabilities.
• Works closely with the BCBA and Behavior Interventionists to provide intervention, conduct assessments, write progress reports and develop programs for assigned cases.
• Supervises Behavior Interventionists to ensure all recorded data is correct and accurate.
• Manages and maintains program records.
• Maintains data reliability and fidelity checks regularly.
• Plans and leads monthly progress updates for each family served with program team.
• Assists in creating and delivering specific intervention activities and provides parent education according to treatment plan or other individualized assessments.
• Monitors the skill acquisition of children and adults diagnosed on the autism spectrum in natural settings.
• Completes necessary documentation including evaluations, treatment notes, progress reports and exit summaries, and keeps updated with other programs, and participant-related documents and reports.
• Provides and coordinates on-going competency-based staff training.
• Attends staff meetings, in-services, treatment planning, trainings, and other meetings, as requested.
• Remains current regarding new research, current trends and developments in autism, ABA, special education and related fields.
• Maintains frequent, professional and courteous communications with participants and families.
• Communicates parental concerns and needs immediately to the case supervisor.
• Performs other duties as assigned.

Clinical Program Manager

• Provides program management and executes changes in program
• Provides specialized behavior intervention services and program supervision to individuals with Autism Spectrum Disorder (ASD) and/or other related disabilities
• Works closely with the BCBA and Behavior Interventionists to provide intervention, conduct assessments, write progress reports and develop programs for assigned cases
• Supervises Behavior Interventionists to ensure all recorded data is correct and accurate
• Manages and maintains program records
• Maintains data reliability and fidelity checks regularly
• Plans and leads monthly progress updates for each family served with program team
• Assists in creating and delivering specific intervention activities and provides parent education according to treatment plan or other individualized assessments
• Monitors the skill acquisition of children and adults diagnosed on the autism spectrum in natural settings
• Completes necessary documentation including evaluations, treatment notes, progress reports and exit summaries, and keeps updated with other programs, and participant-related documents and reports
• Provides and coordinates on-going competency-based staff training
• Attends staff meetings, in-services, treatment planning, trainings, and other meetings, as requested
• Remains current regarding new research, current trends and developments in autism, ABA, special education and related fields
• Maintains frequent, professional and courteous communications with participants and families
• Communicates parental concerns and needs immediately to the case supervisor
• Performs other duties as assigned

• Lead and manage global Phase I clinical trials from study start-up through database lock and closeout with minimal oversight
• Serve as the operational lead responsible for driving study execution, timelines, deliverables, risks, and overall trial performance
• Partner cross-functionally with Clinical Operations, vendors, study teams, and stakeholders to ensure seamless trial execution across all phases of the study lifecycle
• Maintain close oversight of study details, proactively identifying operational gaps, risks, and delays before they impact timelines or quality
• Manage vendors closely to ensure accountability, quality deliverables, budget adherence, and successful execution against study expectations
• Drive study team meetings by developing agendas, facilitating discussions, documenting decisions, and ensuring follow-through on action items
• Navigate fast-paced, high-visibility environments with the ability to prioritize effectively and adapt quickly to changing business needs
• Ensure studies remain inspection-ready and compliant with GCP, SOPs, regulatory requirements, and sponsor expectations
• Support issue escalation and resolution while maintaining strong stakeholder relationships and collaborative team dynamics
• Contribute to process improvement initiatives and operational best practices that enhance study execution and team effectiveness
• Lead with a solutions-oriented mindset while fostering accountability, transparency, and collaboration across teams

Clinical Project Manager II – Virology

• Oversee operational delivery and vendor management activities for early-phase virology clinical trials
• Manage and oversee vendors to ensure quality deliverables, timelines, and study expectations are consistently met
• Coordinate cross-functional clinical trial activities from study start-up through closeout with minimal oversight
• Drive meeting leadership by setting agendas, facilitating productive discussions, documenting decisions, and ensuring accountability for action items
• Partner closely with Clinical Operations, study teams, vendors, and stakeholders to proactively identify and resolve operational challenges
• Ensure effective communication across teams while maintaining professionalism and strong stakeholder relationships
• Monitor study progress, timelines, risks, and operational deliverables to support successful trial execution
• Support inspection readiness and compliance with applicable SOPs, GCP, and regulatory requirements
• Lead with a solutions-oriented mindset while helping align teams toward shared project goals

• Responsible for all functional activities related to execution of Clinical Trials.
• Lead and oversee a team of internal and external clinical project managers/specialists to meet individual clinical trial objectives and corporate goals.
• Provide operational expertise to project teams.
• Directs, supervises and manages all aspects of clinical trials to ensure that corporate and department goals/objectives for clinical development programs are met on time and within budget.
• Interacts with multidisciplinary teams in a matrix environment, developing resourcing, budgeting, financial and strategic planning for clinical programs/studies.
• Create and execute clinical operational strategic plans in line with product strategy and resource allocation.
• Responsible for strategy and clinical operation sections of regulatory documents including data summarization, protocols, Investigator Brochures, IND annual reports, and others as needed or requested.
• Prepare and present clinical development trial updates to senior management, review any potential issues and propose any mitigations/recommendations.
• Develop study feasibility, cost estimates, input into contracts, work/change orders and analyze tools and processes to support outsourcing efforts.
• Build, develop and train internal staff and external vendors, structure department for enhancing efficiency, and create a highly engaged work environment for attracting and retaining highly qualified clinical operations professionals.
• Develop and ensure compliance with SOPs and guidelines, FDA regulations and current ICH GCP guidelines.
• Oversee and maintain the relationships with Contract Research Organizations and investigative sites.
• Participate on project teams and study teams as needed or requested.
• Maintain a high level of professional expertise through familiarity of clinical literature, knowledge of therapeutic area, current medical practice and pharmaceutical regulations.

Senior Director – Clinical Operations

Clinical Operations Manager – RN

• Co-own and execute the early development strategy for the immunology portfolio with the Head of TMed Immunology
• Provide comprehensive strategic planning and operational oversight for immunology clinical programs and trials to ensure efficient, timely execution against milestones
• Ensure appropriate resources, competencies, and partnerships are in place to meet objectives
• Serve as the deep subject matter expert for early immunology clinical operations
• Critically review strategy and clinical program documents (development plans, investigator’s brochures, protocols, etc.), providing scientific and operational insight to ensure best path forward
• Partner with Business Development and Licensing to evaluate internal and external opportunities that align with portfolio strategy
• Actively participate in annual and quarterly planning cycles: identify risks, develop and execute mitigation plans, and track performance metrics and outcomes
• Ensure immunology data integrity across organization (Book of Business, CTMS, etc.)
• Build and sustain strong cross-functional relationships (country operations, clinical supplies, data management, regulatory, etc.) across departments, divisions, and geographies
• Foster the people pipeline: Attract, coach, mentor, and retain talent; provide performance management support; act as ‘player-coach’ to enrich group skillsets
• Represent TMed on enterprise strategic initiatives and lead continuous-improvement efforts that increase program efficiency and scientific impact
• Serve as a member of the TMed U.S. Clinical Operations leadership team and contribute to shaping department strategy

Translational Medicine Clinical Operations Lead – Immunology

• Drive the AI-native Development Operations strategy and roadmap, anchored to measurable clinical trial outcomes.
• Lead prioritization for AI opportunities across Development Operations in line with the AI-native Development Operations strategy and R&D priorities.
• Continuously scan the external landscape for emerging AI capabilities, frontier tools, vendor offerings, and new ways of working, translating relevant developments into clear implications for Development Operations strategy, portfolio priorities, and build-buy-partner choices.
• Define the build-buy-partner approach for each priority capability, including vendor and partner evaluation where needed, balancing speed, differentiation, risk, cost, and long-term platform value.
• Build and defend business cases with clear ROI, payback logic, and success criteria; enforce stage-gate discipline, including the decision to stop or reshape initiatives that do not demonstrate value.
• Shape the deployment strategy and roadmap with enterprise AI, technology, data, security, regulatory, and quality teams to ensure scalable and compliant delivery using shared foundations rather than one-off point solutions.
• Drive cross-functional alignment and endorsement for the AI-native Development Operations strategy across the enterprise.
• Partner with leaders across R&D to identify priority workflow bottlenecks, define measurable outcomes, and shape AI-native capabilities.
• Lead 0-to-1 incubation for priority opportunities: frame hypotheses, use AI-native development tools to run hands-on experiments with technology teams and business SMEs, and define the evidence required to scale, reshape, or stop.
• Define adoption strategy for priority AI-native capabilities, including workflow redesign, user readiness, and change interventions required for scaled deployment.
• Stakeholder Management: Leaders across R&D to identify priorities, secure sponsorship and align on value. Leaders across enterprise AI, technology, security, and quality teams to enable scalable deployment. Strategic relationships with external vendors, consulting partners and technology providers to assess capabilities, shape partnerships and deliver value. Frontline users across Development Operations to ensure solutions solve real problems and value is realised at scale.

AI Strategy Director – Global Clinical Development Operations

• Provide end-to-end operational leadership for complex clinical trials from start-up through close-out, ensuring delivery on time, within budget, and in compliance with global regulations and company SOPs
• Lead cross-functional study teams and drive alignment across Clinical Development, Regulatory, Biometrics, and external partners
• Develop and execute enrollment, site management, and monitoring strategies to ensure high-quality trial conduct and performance
• Oversee CRO and vendor performance, including KPI management, monitoring quality oversight, document review and approval, and vendor selection support
• Partner with Data Management and Medical to conduct ongoing data review and ensure timely query resolution
• Develop and manage key study documents and operational tools, including protocols, informed consent forms, project plans, budgets, and study materials.
• Lead study-related training for investigators, site personnel, and internal teams.
• Proactively identify, assess, and escalate operational risks with mitigation strategies and clear recommendations.
• Mentor and support junior clinical operations staff, including potential dotted-line management responsibilities.
• Travel up to 10% as required to support study oversight and site engagement

Senior Clinical Trial Manager, Clinical Operations

• Build and lead a scalable, high-performance clinical operations function
• Establish systems, processes, and operating models for multi-site clinical trials
• Define and implement clinical operations infrastructure including site management strategies
• Ensure consistent, inspection-ready execution across clinical studies
• Lead a growing Clinical Operations team and enable strong program leadership

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