Clinical Operations

• Contributes to the development of clinical strategies aligned with regulatory and commercial goals.
• Collaborates with R&D, Regulatory, and Marketing on clinical trial designs and endpoints.
• Prepares and presents findings of assigned studies to internal and external stakeholders.
• Leads and manages the execution of assigned clinical studies.
• Oversees protocol development, site selection, budgeting, contracting, and CRO/vendor management for assigned studies.
• Ensures adherence to timelines, budgets, and enrollment targets.
• Manages resources and quality of clinical projects.
• Ensures all clinical activities for assigned studies are compliant with FDA, ISO, and ICH-GCP regulations.
• Prepares and reviews study documents including protocols, informed consent forms, monitoring plans, and clinical study reports.
• Acts as a liaison with Director, Clinical Research to manage the Clinical Research Associates’ monitoring activities, reports and timelines.
• Identifies study risks and proactively implements mitigation strategies.
• Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture.

Clinical Project Manager

• As an intern, you will have the opportunity to rotate through various roles to gain experience in Clinical Delivery.
• Performs all tasks in accordance with applicable guidelines, (e.g., ICH-GCP), company and sponsor SOPs, project plan, study-specific processes, local regulatory requirements.
• Completes essential document collection and review throughout the study lifecycle, organizes and maintains site clinical trial master file (TMF) documents, and maintains site-related data in applicable clinical systems according to procedures and guidelines.
• Ensures timely and complete data entry into CTMS.
• Performs risk assessment and management responsibilities throughout the project including site process evaluation, addressing follow up items and issue escalation.
• Manage additional clinical operations tasks as required and outlined in study job task list.
• Facilitate ordering and tracking of trial materials as needed.
• Assist project teams with trial progress tracking by updating the Clinical Trial Management systems, providing access to study/client systems (as appropriate).

Excel Intern – Clinical Operations

• The "First Impression": Conduct rapid outreach to new referrals, welcoming them to the program and setting the tone for their care journey.
• Intake & Eligibility (The VOB): Perform Verification of Benefits (VOB) and confirm program qualification to ensure a seamless billing path.
• The Calendar Lead: Own the scheduling and rescheduling loop. You are responsible for ensuring patients and providers show up for their E/M visits and resolving "no-show" hurdles.
• Tech Troubleshooting: Act as a "Member Concierge," helping patients and providers navigate our platform, sign consents, and fix audio/video issues before their appointments.
• Data Integrity: Maintain a "Zero Inbox" mentality within our Case Management Systems, ensuring every interaction is documented for clinical continuity and reimbursement.
• Startup Agility: Assist the Operations team in testing new workflows, documenting "what works," and taking on special projects as the company scales.

Clinical Operations Associate – Care Delivery

• Oversee the operations of a service site, ensuring optimal performance, safety, and customer satisfaction
• Mentor a team to uphold the organization's central beliefs
• 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

• Cultivate an environment focused on safety at the site, promoting continuous improvement in safety performance.
• Develop and empower your team to efficiently operate and maintain wind turbine plants.
• Establish robust partnerships with clients to guarantee the fulfillment of contractual commitments.
• Manage costs adequately to meet budgetary targets for service contracts.
• Coordinate planned maintenance and diagnostic efforts to improve turbine performance.

• Provide project management and change management across multiple GCO projects & initiatives and assess / monitor impact
• Lead optimization of assigned GCO processes, organization and support decision making.
• Lead development & tracking of goals & key performance indicators for GCO
• Support Leadership in the areas of Business Strategy, Operational Insights Generation and Cross Functional Engagements.
• Collaborate with teams within GCO and other functions to deliver on commitments to the organization and to patients
• Provide support for insights driven GCO strategic & operational decision-making by leveraging internally & externally available data sources
• Plan, track, and manage progress of the GCO goals/objectives and other performance indicators
• Develop and lead cross-functional teams in brainstorming new approaches in driving efficiencies & other improvement measures.
• Plan, execute key GCO initiatives, and assess impact
• Lead/support planning, execution, and delivery of assigned GCO projects and initiatives, ensuring alignment with strategic objectives, mitigating risks, and collaborating with cross-functional teams to drive change and scalable, high-impact outcomes.
• Develop, implement, and oversee the methodology, system(s), and tactical process for managing the portfolio of GCO projects.
• Support the Office of GCO team members in the implementation of a framework and methodology for GCO project prioritization and ensure alignment with annual goals, and strategic imperatives.
• Establish and drive timely execution of actionable project plans for the projects.
• Support the project teams in the development of business cases for key GCO projects to assess and quantify business opportunity across key criteria (i.e. cost saving, improvement to compliance and/or quality etc.) to enable ongoing prioritization.
• Coordinate project team meeting schedules, prepare agendas and minutes, track decisions and action items and progress reports according to project management best practices.
• Work with the cross-functional project teams to enable alignment, drive advancement of project deliverables, define, capture and track status/milestones, issues, and risks to the project.
• Represent the Strategic Operations Team & GCO in collaborations with internal and external stakeholders as appropriate.

Senior Project Manager, Strategic Operations, Global Clinical Operations

• Leads the execution of the Clinical strategy and business plan
• Builds and maintains a high-performance culture through championing effective performance, processes, communication, and coaching and development of staff
• Provides timely, relevant, and accurate reporting to the Head of US Clinical &/or Executive team
• Effectively manages client and other stakeholder expectations through relevant communication
• Coordinate and assign tasks to clinical personnel and ensure projects are compliant with Good Clinical Practice Guidelines (if applicable) to deliver high quality data to the study Sponsors
• Implement, and maintain strategies and training for CTM, CRA, and Clinical Support teams
• Recommends, develops, and regularly facilitates innovative learning for Clinical Research Associates of all levels. Training should be evaluated regularly and updated as the needs of the business unit change. Facilitation is co-facilitated among the CRA Team Leads

Manager, Clinical Operations

• Manage and support a caseload of up to 20 impact hours per week
• Work in close collaboration with Regional Clinical Integrity Officer (CIO)
• Provide ongoing clinical mentorship and support for BCBA team
• Host bi-weekly BCBA team meetings
• Conduct treatment plan reviews and provide feedback
• Travel to schools to overlap with supervision
• Conduct clinical interviews for BCBAs and RBTs

Clinical Operations Director, BCBA

• 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

• Coordinate projects and initiatives supported by the department, including preparation of reports, researching triaging requests and referrals, updating workflows and policies, procedures, manuals, and administrative tools
• Provide administrative support for the following initiatives, supported by Care Continuum Teams:
• Patient support funds
• Advance care planning
• Social determinants of health
• Other projects/programs as needed
• Aide in the organization and review of incoming requests/referrals and provide timely feedback to ensure departmental staff are able to respond to the needs of patients and families

Clinical Operations Assistant, Ambulatory Social Work

• Own our clinical service operations end to end: clinician supply, capacity, scheduling, care delivery performance, and quality across all encounters.
• Build the recruiting, credentialing, and licensing engine, and scale our clinician workforce to meet aggressive growth targets across multiple states.
• Develop and oversee clinical quality, including clinical SOPs, documentation standards, supervision structures, and medical-necessity rigor, ensuring consistent, high-quality, and compliant audit-ready care delivery.
• Design, pilot, and scale our longitudinal care program, including eligibility, consent, matching, time-tracking, and billing.
• Build and lead key teams: clinical providers, care management, and clinical HR / credentialing.
• Own the clinical P&L, optimize our staffing models, and transition us from external reliance to a proprietary, high-quality, and cost-efficient operating model.
• Define and monitor the operational and clinical KPIs that drive quality, access, efficiency, and profitability, using data to continuously improve performance.
• Join the leadership team and partner across Fulfillment, Patient Experience, Revenue Cycle, Product, and Engineering.

Head of Clinical Operations

• 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

• Facility management of a newly constructed electric vehicle battery manufacturing plant
• Manage hard services of MEP equipment within the facility
• Ensure seamless environment for uninterrupted manufacturing
• Oversee operational performance across both day and night shifts
• Manage supervisors and staff, including hiring and performance evaluations
• Provide technical and management guidance to the team

Operations & Maintenance Site Operations Manager

• Own resourcing decisions and workforce planning strategies for assigned clinical programs and portfolios
• Partner with Clinical Operations leadership to proactively identify staffing needs and develop resource solutions
• Balance competing resource demands while ensuring business priorities and study timelines are met
• Lead prioritization discussions when resource demand exceeds available capacity
• Manage complex resourcing escalations and workforce planning challenges
• Interpret forecasting data and translate demand signals into actionable workforce plans
• Monitor utilization trends, forecast variance, assignment accuracy, and resource availability
• Identify hidden capacity and staffing opportunities across portfolios
• Utilize Power BI dashboards and workforce planning tools to analyze: Resource utilization, Capacity planning, Forecast variance, Assignment discrepancies, Hiring demand signals, Workforce trends
• Facilitate resource planning discussions with senior business and operational leaders

Clinical Operations Resource Manager – Clinical Resourcing

• 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

• Serve as an integral part of the Clinical Operations core team to drive operations efficiently including generating integrated project plans, identifying and tracking key project milestones and metrics, and monitoring budgets, invoices, and accruals.
• Provide cross-functional transparency of the clinical trial(s) progress to ensure team is efficiently progressing forward with deliverables, including deliverables from CRO and other partners.
• Organize internal and external meetings (development of agendas, minutes, and presentations)
• Manage ancillary supplies for clinical trials
• Support risk management including risk assessment, mitigation planning, and internal and external audit preparation and follow-up
• Contribute to development of clinical study plans and manuals, including version tracking and team training.
• Provide support to senior leadership in defining the deliverables on the clinical trial(s) which coincide with the expectations defined in the departmental and company goals.
• Maintain ongoing communication with team members and all stakeholders including senior leadership and external partners or vendors.
• Foster a sense of inclusion and create a shared sense of purpose.

Senior Project Manager, Clinical Operations

• Support the development of project related deliverables including the project management plan, overall clinical budget, study timeline, risk management / contingency plan, monitoring plan, communication plan, etc.
• Responsible to develop of study related documents, including protocol, informed consent, IB, regulatory binder, training materials, etc. and provide input to case report forms.
• Responsible to manage and track the overall study budget, track and administer payments, and provide financial updates.
• Responsible for the proactive management and conduct of clinical trials.
• Provide centralized site support, communication and coordination to assure timely completion of start-up, enrollment and all other study activities.
• Assist in the review site visit reports and enrollment progress and monitors the study for protocol, federal, and local compliance.
• Support vendor selection process, including RFP to contract and change order process for CROs and other external service providers (ESP).
• Provide day to day management of ESPs ensuring quality deliverables and adherence to the scope of work;
• Manage clinical supply shipments and inventory.
• Ensure compliance with Terumo policy, procedures and SOPs, GCP, and local, regional and federal regulations.
• Provide periodic updates, reports, etc. as requested.
• Manage ongoing communication of operation issues and provides progress reports to the study team.
• Assist with Database freeze, Database lock, annual progress reports, and final clinical study reports.
• Responsible for Site Management and Monitoring as required.

• Create, manage, and maintain integrated study schedule in MS Project, including Key Event Maps, Roadmaps, and critical path visualization aligning in Planisware.
• Assure Clinical timelines in Planisware align to MS Project schedule and coordinate the integrated clinical plan with Clinical Development Team project plans.
• Ensure proper resource demand is reflected.
• Develop scenarios in Planisware for budget, timeline, and FTE forecasting, while generating situational operational scenarios.
• Collect, consolidate, and report financial, timeline and resource data for governance approvals and external funding partnerships.
• Manage scope control, FTE and Out of Pocket variances.
• Document key decisions, actions, risks, issues, and lessons learned, as well as maintain trial governance documentation.
• Ensure risks are captured and monitored.
• Ensure budgets are effectively managed and forecasts adjusted to reflect current thinking.
• Drive and facilitate after action review meetings and results are documented.
• Work with the team to assess and remediate impact to scope, budget, timelines.
• Provide support for team-based reporting.
• Mentor & support onboarding of new team members, particularly those in Trial Management.

Senior Clinical Project Manager, Analyst

• Create, manage, and maintain integrated study schedule in MS Project, including Key Event Maps, Roadmaps, and critical path visualization aligning in Planisware.
• Assure Clinical timelines in Planisware align to MS Project schedule and coordinate the integrated clinical plan with Clinical Development Team project plans.
• Ensure proper resource demand is reflected.
• Develop scenarios in Planisware for budget, timeline, and FTE forecasting, while generating situational operational scenarios.
• Collect, consolidate, and report financial, timeline and resource data for governance approvals and external funding partnerships.
• Manage scope control, FTE and Out of Pocket variances.
• Document key decisions, actions, risks, issues, and lessons learned, as well as maintain trial governance documentation.
• Ensure risks are captured and monitored
• Ensure budgets are effectively managed and forecasts adjusted to reflect current thinking
• Drive and facilitate after action review meetings and results are documented
• Work with the team to assess and remediate impact to scope, budget, timelines
• Provide support for team-based reporting
• Mentor & support onboarding of new team members, particularly those in Trial Management.

Senior Clinical Project Manager

• Support the Study Lead and cross-functional study team in day-to-day clinical trial operations
• Support activities such as: Clinical Trial Team (CTT) meeting coordination and minutes, Clinical supplies planning and tracking, Lab specimen tracking and reconciliation, Imaging data reconciliation, Study status reporting and updates, Study closeout activities
• Contribute to single or multiple studies, depending on scope and complexity
• Lead smaller or limited-scope studies, as appropriate (e.g., survival follow-up studies)
• Track and manage study timelines using project management tools
• Collaborate with internal stakeholders and external partners, including investigative sites, vendors, and committees
• Support achievement of study milestones and clinical objectives

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