Clinical Operations

• Manager Clinical Operations is accountable for the operational management and successful country execution of all phases of clinical trials within assigned therapeutic area(s) or specific role(s).
• Responsible for resource allocation, adherence to timelines and budget, and compliance with relevant Standard Operating Procedures (SOPs) and policies.
• Supports Country Head in shaping and managing local organizational structure for optimal efficiency.
• Responsible for line management of Local Trial Managers (LTM), Site Managers (SM), Clinical Trial Assistants (CTA) and/or other GCO staff.
• Oversees staff performance, development, training, project assignments, and workload distribution.
• Ensures alignment of local goals with organizational objectives.
• Drives innovative solutions and process improvements within assigned therapeutic area(s).

Manager, Clinical Operations

• Deliver onboarding and refresher training for nursing and MA teams on EMR workflows, documentation standards, triage, and clinical protocols
• Reinforce best practices and ensure consistent implementation across offices
• Provide on-site support and direct patient care as needed during training or process rollout
• Develop and maintain updated training materials, reference guides, and SOPs for clinical procedures
• Coach RNs, MAs, and other clinical staff to improve efficiency, communication, and adherence to workflows
• Model effective patient care standards and clinical documentation practices
• Identify performance or process gaps and provide structured feedback to leadership
• Conduct audits of clinical documentation, patient safety practices, and compliance with organizational standards
• Analyze audit data to highlight trends, training needs, and areas for improvement
• Provide clear, actionable insights to the Assistant Medical Director and medical leadership team
• Track progress of clinical initiatives and workflow improvements, ensuring timely completion of milestones
• Support rollout of new clinical technologies, protocols, and quality programs
• Collaborate with Administrative-based CDM to align cross-functional initiatives and maintain consistency between nursing and administrative workflows

RN Clinical Development Manager – Process & Performance Improvement, Nurse Educator

• Champion QVC’s customer-first culture by leading with enthusiasm, modelling company values, and fostering a positive, motivating work environment.
• Supervise daily operations for the assigned area by prioritizing, assigning and reviewing work to achieve productivity, volume and quality targets.
• Maintain a clean, safe and compliant workplace by upholding company policies, procedures, performance standards and operational plans.
• Identify performance trends, issues and process gaps, then develop and implement effective solutions through proactive problem-solving and team involvement.
• Lead, coach and develop both base and flex employees through regular feedback, performance reviews, training, and partnership with managers and HR on action plans.
• Support departmental success through cross-functional collaboration, staffing program improvement, team communication, administrative reporting, and contribution to long-term goals and continuous improvement initiatives.

Area Manager – Site Quality 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

• Lead administrative and operational coordination across the clinical trial lifecycle.
• Independently manage study trackers, site updates, enrollment metrics, and operational reporting.
• Prepare agendas, lead or co-lead portions of meetings, and finalize high-quality minutes and action items.
• Coordinate cross-functional workflows with CRAs, PMs, Data Management, SSU, Safety, and TMF teams.
• Provide proactive solutions and anticipatory support to internal teams and Sponsor clients.
• Independently manage essential document collection, QC, and readiness for site activation.
• Conduct feasibility outreach, site qualification support, and site-level intelligence collection.
• Perform advanced QC review for TMF documents and root-cause identification for recurring issues.
• Perform high-level clinical data review in EDC systems; generate and track complex queries.
• Serve as a point of contact for assigned vendors or site-level workstreams.
• Support internal SOP/process improvements and contribute to template refinement.

Clinical Operations Specialist

• Oversee daily operations of a team of 20-25 non-exempt quality assurance clinical technicians
• Track and evaluate staff performance metrics, implementing process improvements to meet or exceed quality and efficiency goals
• Provide coaching, guidance, and recognition to foster a high-performance culture
• Manage customer service in high-volume environments, ensuring efficient escalation and recovery processes to meet service excellence standards
• Ensure compliance with FDA regulations and company policies, collaborating with cross-functional teams to maintain and uphold these standards
• Contribute to strategic planning and leadership initiatives, working closely with senior management to achieve long-term organizational goals
• Oversee team budget, managing resources and additional hours needed to achieve targets
• Facilitate ongoing staff development by coordinating training with clinical teams to meet performance and quality standards
• Assist with quality management programs, provide feedback on operational efficiencies, and collaborate on cross-functional projects to support company-wide initiatives
• Utilize workflow automation tools and performance dashboards to monitor team performance and operational metrics, ensuring alignment with organizational goals

Manager, Clinical Quality

• Provide direct leadership and supervision to AVP-level clinical leaders
• Ensure accountability, performance management, and cross-functional alignment
• Develop and maintain enterprise-wide clinical strategies, policies, and procedures
• Allocate and manage clinical caseloads across clinical teams
• Ensure ongoing compliance with all established policies, protocols, and regulatory requirements
• Establish and lead quality improvement initiatives
• Oversee grievance and complaint management processes
• Drive clinical program integration
• Support provider network expansion and development
• Deliver crisis counseling support as appropriate
• Develop and regularly deliver executive-level reporting on clinical operations
• Provide quality assurance oversight to client clinical reporting
• Support organizational growth initiatives
• Provide clinical leadership in cross-functional collaboration
• Must be willing to travel to the San Francisco Bay Area approximately 15% of the time

VP, Clinical Operations

• Set the strategic direction for clinical science and operational execution across the endocrine clinical development portfolio
• Drive alignment across cross-functional teams to anticipate and resolve risks before they impact program timelines or quality
• Build and develop a high-performing team, including Clinical Scientists, consultants, and Clinical Research Project Coordinator
• Own clinical data oversight and ensure clean data, analysis, and interpretation
• Drive the scientific execution of through contribution of key regulatory documents
• Oversee strategic partnerships with CROs
• Identify, escalate, and drive resolution of program and portfolio risks in a timely and structured manner
• Drive continuous improvement and transformation initiatives across the Clinical Science team

Executive Director, Clinical Science, Clinical Research Operations

• Serves in an on-call capacity providing, consistent, comprehensive oversight of all organ donation operations including but not limited to donor referral triage, authorization, management, organ allocation, recovery and post-mortem care. Responsible for providing plan of care guidance, and ensuring all case activity proceeds in an effective and efficient manner.
• Provides regulatory oversight/verification of critical considerations such as hemodilution, death note(s), and PHS Increased Risk reviews.
• Collaborates with DNW Medical Director/Chief Medical Officer (CMO) on setting and upholding donor case plans and interacts with physician consults as needed.
• Advises staff in working through operational challenges by providing mentoring, talking points, and on-site support.
• Provides on-site staff and operations support for procedures and critical staffing needs (i.e. DCD lead, donor management).
• Collaborates with management team on staff development directives.
• Drives organ operations, quality assurance, and performance improvement initiatives. Responsible for identifying trends and performance improvement opportunities in collaboration with Chief Medical Officer and Clinical Educator.
• Collaborates with CMO to develop and maintain evidenced based donor clinical management guidelines.
• Partners with regional management to identify, develop, and implement regional strategies for clinical and hospital education, including but not limited to participating in donor councils, grand rounds, staff meetings and other educational opportunities.
• Responsible for identification and implementation of transplant center (TXC) stakeholder engagement strategies. Serves as the primary point of contact for TXC concerns, leads root cause analysis, proposes improvement plans and implements change to address improvement opportunities. Engages stakeholders by participating on abdominal and thoracic transplant program quality meetings. Engages stakeholders to develop resources for infectious disease consulting, echo core diagnostic group, DNW case plans and timing reviews, and overall performance improvement.
• Collaborates with Research Program Director on evaluation and implementation of research initiatives, particularly those focused on prospective donor management trials.
• Collaborates with referral management team to ensure appropriate resource commitment and process improvement.
• Participate in and lead donor performance improvement meetings (QAPI, MAB, educational forum, etc).
• Performs additional responsibilities and projects as assigned.

Clinical Operations Manager

• Drive operational execution of Early Phase Oncology clinical trials from study start-up through database lock and closeout
• Independently manage day-to-day study operations with minimal oversight
• Own timelines, deliverables, risks, and issue resolution across multiple workstreams
• Maintain deep operational awareness across all aspects of the trial — this is a role for someone comfortable working "in the weeds"
• Ensure study milestones stay on track in a fast-paced environment with shifting priorities and competing demands
• Partner cross-functionally to proactively identify risks, remove roadblocks, and implement operational solutions quickly
• Support operational activities associated with dose escalation cohorts, dose expansion cohorts, safety review meetings, protocol amendments, enrollment management, and study execution activities
• Monitor enrollment, site performance, data quality, and operational metrics to support successful study execution
• Drive accountability across study teams to ensure timelines and deliverables are met
• Lead vendor management activities and maintain strong oversight of external partners and CROs
• Contribute to RFP development, vendor selection, and ongoing vendor performance management
• Hold vendors accountable to timelines, deliverables, quality expectations, and issue resolution
• Actively manage operational follow-through rather than relying solely on escalation pathways
• Partner closely with CROs, monitoring teams, central laboratories, imaging vendors, and specialty oncology service providers
• Lead cross-functional meetings with clear agendas, action-oriented discussions, and strong follow-up
• Drive accountability across internal teams and external partners
• Build strong collaborative relationships while effectively navigating challenging conversations and competing priorities
• Mentor or support junior team members as needed
• Operate confidently within a matrixed global environment with multiple stakeholders
• Draft, review, and coordinate key study documents including protocols, informed consents, monitoring plans, investigator brochures, clinical study reports, and other essential study documentation
• Support study budget tracking, forecasting, and operational planning activities
• Review data listings and support interim and final reporting activities
• Train CROs, investigators, study coordinators, and vendors on protocol and study requirements
• Support inspection readiness activities and maintain compliance with GCP, ICH, and applicable regulatory requirements
• Contribute to SOP development, process improvement initiatives, and operational best practices

Clinical Project Manager II – Early Phase Oncology

• Lead the planning, execution, and closeout of clinical trials from Phase I–III
• Oversees and manages CROs and vendors to ensure that the study(ies) are completed on time, within budget, and in compliance with RayzeBio SOPs, FDA regulations and ICH/GCP guidelines
• Leads the cross-functional study execution team in achieving the study goals and deliverables
• Plan and execute study timelines
• Monitor study progress, including enrollment, site performance, data quality, and key risk indicators and proactively escalates issues to key internal stakeholders to ensure timely resolution of issues
• Identify, assess, and mitigate operational risks; escalate issues as needed
• Manage study CRO and vendor budgets and invoicing procedures according to study contract
• Lead/support country and site feasibility, selection, and activation strategies
• Active participant in CRO and vendor meetings, responsible to review key CRO and vendor study operational plans and provides input to operational strategy, including country and site feasibility and start-up
• Summarizes CRO, vendor and site performance data and escalates study risks to the Clinical Operations Program Lead / Head of Clinical Operations
• Performs other related duties as assigned

Clinical Trial Manager, Clinical Operations

• Manage a team of direct and potentially indirect reports.
• Oversee and be responsible for the successful execution of studies and/or multiple studies within a program or multiple programs, including financial responsibility.
• Responsible for the resource management of studies, including ongoing assessment of resource needs and optimal deployment of resources to support a fluid ‘One Ops’ workforce.
• Participate and engage in Clinical Operations and/or cross-functional organizational change initiatives.
• Act as the business process owner (BPO) and/or serve as a subject matter expert for Clinical Operations processes.
• Encourage an innovative mindset by championing new ideas and initiatives and incorporating best practices, external benchmarking and standardization across Clinical Operations.
• Hire, develop and retain diverse top talent on the team.
• Set clear goals for the team and individuals direct reports.
• Coach direct reports on their performance, development and career interests.
• Provide input into strategic and operational plans as appropriate, including supporting alignment and communications to other team members upon implementation.
• Act as team leader and builder; providing guidance and oversight for the successful management of all aspects of clinical trials within designated program budgets and timelines.
• Lead cross-functional Study Management Teams (SMTs) and influence all relevant stakeholders.
• Partner with cross-functional teams to manage, adjust and revise project timelines and budgets as needed.
• Communicate project status and issues and ensure project team goals are met in alignment with project decisions.
• Escalate issues as needed.
• Participate in the development of all study-related documentation, including study protocols.
• Participate in the selection and management of contract research organizations (CROs) / vendors, including development of requests for proposals (RFPs).

Clinical Program Manager

• Lead Parexel and Sponsor teams by leveraging clinical research experience and project management skills to develop tailored solutions for sponsors
• Ensure operational excellence and successful execution of clinical operations and logistical strategies for EP clinical trials or programs
• Manage the financial aspects of projects, including revenue recognition, milestone payments, and monthly pass-through invoices
• Own the sponsor relationship and manage sponsor communication
• Manage study start-up activities and ensure best practices are implemented
• Monitor study timelines, recruitment, retention, and data cleaning
• Oversee administrative closeout procedures and ensure project documentation is archived

Clinical Project Manager – Early Phase Trials

• Provides leadership and therapeutic expertise for the successful management of international clinical trials (Phase I - IV)
• Responsible for oversight and strategic direction across multiple projects
• Initiates continuous efforts in reviewing and identifying best practices among study teams
• Directs development of SOPs within department
• Manages study teams to ensure deployment of resources
• Travels nationally and internationally as required
• Represents the company at professional events

Director, 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

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