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.

Clinical Project Manager

• 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

• Provide strategic input into the global development plan
• Direct, supervise and manage all operational aspects of global clinical projects
• Ensure quality deliverables on time and within budget
• Lead large, complicated program development and/or multiple programs simultaneously
• Teach, coach and mentor direct reports

Clinical Operations Project Lead

• Contributes to the scientific planning and execution of one or more clinical trials.
• Assists the Lead Clinical Scientist and study team with the scientific conduct of clinical studies.
• Develops leadership, technical skills, and scientific acumen as part of a global, cross-functional team.
• Responsible for specific clinical/scientific activities on a single study or across multiple studies (e.g., medical monitoring, lab specimen tracking/reconciliation, adjudication support, preparation of meeting materials).
• Supports development of Protocol and related study materials (e.g., ICF documents/amendments, data management deliverables).
• May interact with internal and external stakeholders (e.g., country operations, committees, vendors) in support of clinical study objectives.
• Prepares clinical narratives
• Collaborates cross-functionally to monitor clinical study data to ensure quality, completeness, and integrity of trial conduct.
• Participates in CRF design to ensure data collection is in alignment with the protocol.

Scientist, Clinical Operations

• Contributes to the operational planning and execution of one or more clinical trials
• Develop leadership and technical skills as part of a global, cross-functional team
• Apply project management, communication, and collaboration skills in support of clinical trials
• May have specific operational responsibilities for a single study or across multiple studies
• May be responsible for tracking study timelines using project management tools
• Shares technical expertise with team members
• May interact with internal and external stakeholders in support of clinical trial objectives

Clinical Operations Scientist

• Responsible for the operational planning, feasibility, and execution of a clinical trial.
• May serve as the clinical trial team lead.
• May lead team in key study planning, development, and execution elements (e.g., data management deliverables, trial level plans/timelines, country/site selection, site materials, system updates, investigator meeting planning, communication plans, preparation of status update reports, study close out activities).
• Leads team for timeline management, risk identification and mitigation, issue resolution.
• May facilitate and collaborate with key internal/external stakeholders (e.g., study team, country teams, vendors, committees) in support of clinical study objectives.
• Accountable for managing any study specific partners and/or vendors.

Senior Scientist, Clinical Operations

• Drive scientific planning, strategy, and execution of Phase 1-4 clinical studies
• Collaborate with global cross ­functional team members including clinical directors and study managers
• Responsible for the clinical/scientific execution of clinical protocol(s)
• Serves as the lead clinical scientist on the clinical trial team
• Collaborates with the Medical Writer on clinical/scientific and regulatory documents
• Partners with Study Manager on study deliverables
• Participates in the set up and design during study start up
• Lead medical monitoring team in review and interpretation of clinical data/medical protocol deviations

Associate Principal Scientist, Clinical Operations

• Provide line management to direct reports, including setting goals and objectives, performance evaluation and talent development.
• Evaluate and forecast resource needs for assigned portfolio and/or other specific areas of responsibility, as required and agreed with local DU management accordingly.
• Deployment of the One Delivery Model through collaboration and oversight of vendors.
• Accountable for the acquisition of new talents and development of human resources.
• Guide direct reports in issue resolution and communication with involved stakeholders.
• Lead organizational changes and effectively communicate on priority shifts as required.
• Review and approve expenses in compliance with the company policies.
• Demonstrate leadership behaviors in alignment with Johnson & Johnson Leadership Imperatives.
• Foster an environment that encourages sharing of ideas, information and best practices (internal and external to the organization).
• Provide coaching and mentorship as needed, including conduct of accompanied site visits as appropriate.
• Define, execute or support long-term strategy in alignment with DU, GD and Johnson & Johnson Innovative Medicine (JJIM) R&D strategies to position the local and global DU organization for success.
• Oversight of execution and monitoring of clinical trials through all phases (from feasibility to close-out) and ensuring inspection-readiness within assigned therapeutic area(s) and/or other areas of responsibility, as required.
• Accountable for ensuring relevant operational objectives are met in conformance to International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP), relevant SOPs and other procedural documents.
• Accountable for appropriate and timely issue escalation and reporting (suspicion) of fraud, scientific/ethical misconduct and health care compliance breach.
• Contribute to Corrective and Preventative Action (CAPA) and issue resolution in accordance with required timelines.
• Shape and maintain strong relationships within local DU department and Local Operating Company (particularly with Medical Affairs) and other key internal and external stakeholders.
• Develop country capabilities for an effective study placement within assigned therapeutic area(s) and/or other areas of responsibility, as required.
• Accountable for robust feasibility process and oversight of site selection to deliver on country commitments within assigned therapeutic area(s) and strategic goals.
• Review operational and quality metrics regularly and drive follow-up actions as appropriate.
• Drive innovative solutions and process improvements for the assigned therapeutic area(s), country, and DU/GD overall.
• Foster a culture of continuous improvement and innovation within the local DU team.

Associate Director, Clinical Operations – Study Start-up

• Build and Lead the OpEx Function
• Establish the OpEx vision, operating model, organizational structure and multi-year road map
• Build and mentor a high performing operational excellence team capable of driving enterprise transformation
• Partner with EPIX functional leads to embed operational discipline across the clinical lifecycle and GCO
• Standardize Operating Models
• Assess current operating models, map E2E processes to gain efficiency and speed.
• Design harmonized, scalable processes and frameworks for planning, forecasting, feasibility, budgeting, execution, enrollment management and closeout.
• Develop governance structures that drive consistency and eliminate operational variability across functions and geographies
• Lead "way of working" harmonization across Innovative and Generics portfolios
• Own Metrics and KPI Governance
• Define and maintain the metrics performance aligning KPI's to quality timelines, predictability, vendor performance, patient/site experience, and cost
• In collaboration with a partner organization, design dashboards and performance reviews that inform decisions at study/ functional/portfolio levels
• Collaborate with other functional areas to establish governance and steering committees
• Ensure metrics are actionable, driving accountability escalation and performance improvement
• Lead Enterprise Level Operational Initiatives
• Champion continuous improvement across planning, execution, governance, and vendor management
• Drive adoption of new processes systems tools and behaviors through structured change management and training
• Shape operational decision-making frameworks that support portfolio level prioritization and resource allocation
• Drive process simplification and implement technology enhancements to optimize speed, accuracy, and efficiency.
• Ensure Organizational Readiness and Scalability
• Define readiness criteria for key study milestones and ensure teams are equipped to meet them
• Build operating structures that support portfolio expansion new modalities and increasing trial complexity
• Align operational excellence strategies with technology, digital and AI/ML teams to maximize adoption and impact
• Oversee resource allocation and governance for GCO

Senior Director, Head Operational Excellence, Global Clinical Operations

• Support the oversight and execution of global clinical trials from study start-up through closeout.
• Ensure clinical studies are conducted according to protocol, GCP, SOPs, regulatory requirements, and timelines.
• Manage departmental budget; effectively managing change orders and out of scope work.
• Monitor study progress, enrollment, quality metrics, and operational risks.
• Collaborate with cross-functional teams including Clinical Development, Medical Affairs, Regulatory, Data Management, Biostatistics, and Pharmacovigilance.
• Act as deputy to the Head of Clinical Operations during periods of absence.
• Assist in developing and implementing Clinical Operations strategies aligned with organizational objectives.
• Drive operational planning, resource allocation, and budget management for clinical programs.
• Identify risks and implement mitigation strategies to ensure successful study delivery.
• Contribute to portfolio planning and operational feasibility assessments.
• Ensure vendor deliverables meet quality, timeline, and budget expectations.
• Participate in vendor selection, contracting, and governance processes.
• Ensure inspection readiness across clinical programs.
• Support internal audits and regulatory inspections.
• Contribute to the development and maintenance of SOPs, processes, and quality systems.

Deputy Head of Clinical Operations

• accountable for the execution of operational quality activities within the assigned therapeutic area
• oversee headquarters clinical quality operations and support clinical trial teams
• embed quality into the Company's sponsored trials
• ensure adequate vendor oversight and address quality issues
• develop quality plans to implement quality by design within clinical development programs
• maintain ongoing inspection readiness
• prepare for, manage and follow up on regulatory inspections

Clinical Quality Operations Manager, Oncology

• Optimize and develop clinical workflows to support both clinician and patient experience
• You will develop mastery using EHR systems and our internal tools to help create best in class clinical workflow and processes
• Receive, monitor, and analyze incoming lab results daily, following appropriate escalation procedures when necessary
• Collaborate with key external vendors and suppliers to enable the delivery of lab and imaging services
• Monitor clinic phone - handling patient, clinician, lab, and pharmacy calls
• Work in collaboration with pharmacy, insurance, and enterprise partners on resolution of escalated patient or partner issues.
• Required-on call shifts monitoring Critical Lab Phone Line - (24/7)
• Prepare prior authorizations requests
• Efficiently process and send EMR Requests
• Additional clinical and administrative duties as required

Clinical Operations Specialist, LPN

• responsible for working with the Clinical Operations team to deliver high-quality, client-centered, and profitable approaches to clinical startup services
• proactively drives projects during the startup phase and interacts with clients as a startup subject matter expert
• build and maintain strong client relationships and mutually beneficial long-term partnerships
• lead and oversee clinical study startup teams and project start up activities
• partner with Clinical Operations Leads, Project Managers, sponsors, and cross-functional teams to develop and execute effective startup strategies
• actively drive study startup performance across site identification, feasibility, site selection, ethics/regulatory submissions, site activation, contract and budget negotiations, and essential document collection
• ensure quality and completeness of startup deliverables by performing reviews of regulatory submissions, essential documents, startup trackers, and study records
• monitor project startup timelines, KPIs, cycle times, and quality metrics
• provide leadership, mentoring, and line management for Clinical Trial Assistants and Site Contracts/Budgets teams
• perform business analysis and benchmarking within startup services and identify opportunities for continuous improvement

Associate Director, Clinical Operations – Study Startup

• The Senior Project Manager position is responsible for taking a leadership role in facilitating the efforts of functional area directors and managers in project planning
• Identification of tasks and deliverables
• Assessment of resource needs and utilization
• Risk identification/mitigation
• Performs overall company-wide project progress tracking utilizing strategic planning and project tracking methods and tools
• Ensures that ongoing projects under their scope have existing project plans as required by the established Standard Operating Procedures (SOPs)
• Ensures that project progress status is properly tracked and reported
• Issues are promptly identified and resolved
• Work with functional area directors and managers to be jointly accountable for smooth project start up, continuation, and successful completion
• Interact with clients for projection of resource requirements and project management purposes
• Responsible for defining project scope and estimating budgets, planning, directing, leading project activities
• Managing resources and budgets, as well as project team performance of cross-functional teams engaged in clinical research and development activities
• Accountable for reporting of project progress status to Everest internal management and its clients
• Activities including, but not limited to site selection, study start-up, clinical operations, statistics, data management, subject randomization and drug supply management (Interactive Web Response Systems [IWRS]), data monitoring and/or adjudication committees, regulatory submissions, vendor management, and medical/scientific writing
• When required, assist the organization in responding to and preparing for Request for Information (RFI) and Request for Proposals (RFP)
• Defining scope of work and budgets
• Performing contract administration activities.

• Provide country-level oversight of clinical trials from start-up through closeout
• Ensure high-quality data delivery and regulatory compliance
• Collaborate closely with cross-functional teams
• Manage site selection and patient recruitment strategies
• Support project execution and maintain inspection readiness
• Drive risk-based mitigation plans and resolve study challenges

Associate Clinical Project Manager, Sponsor Dedicated

• Coordinate, support, and continuously optimize clinical workflows, provider schedules, onboarding/deboarding processes, and platform troubleshooting to ensure a seamless care delivery experience.
• Review clinical dashboards for continual improvement and quality assurance.
• Assessment and distribution of weekly clinical dashboards.
• Coordinate clinicians’ calendars, ensuring alignment with patient appointments, supervision sessions, and other required or optional meetings.
• Monitor clinician schedules to ensure clinician productivity and appropriate time and calendar management practices. Identify opportunities for improvement with calendar management and share feedback and recommendations with clinicians and clinical leaders.
• Support the facilitation of patient transfers as necessary, ensuring a smooth process for both clinicians and patients.
• Troubleshoot EHR systems and business platforms to resolve technical issues efficiently.
• Provide clinicians with enrollment assistance, access troubleshooting, and account information management for our EHR.
• Provide onboarding support by training and assisting incoming clinicians.
• Close out patient charts with appropriate documentation and notification.
• Periodically review the Website Directory of providers and escalate to the Clinical Operations Supervisor if a discrepancy or an update is needed.
• Consistently evaluate workflows and Standard Operating Procedures (SOPs) to ensure alignment with organizational priorities, enhance operational efficiency, and maintain high-quality standards.
• Act as a consistent point of contact for assigned care teams, facilitate bi-annual clinician check-ins, and provide year-round guidance, resource-sharing, and operational support. Liase with patients on behalf of providers.
• Ensure providers receive an efficient, thorough, and positive onboarding and deboarding process with thoughtful collaboration of key departments and contributors (People Operations, Marketing, Supervisor of clinician, etc.)
• Conduct formal check-ins twice annually with each clinician to review updates, provide resources, and collaboratively address clinical or patient care needs.
• Lead and contribute to meaningful conversations during check-ins, advocating for patient needs and sharing actionable updates to support clinician success.
• Leverage internal dashboards and reporting tools to monitor productivity, documentation compliance, and patient reengagement opportunities.
• Develop and maintain collaborative professional relationships between operations and clinical departments.

Clinical Operations Coordinator

• Provide leadership to the designated Area within CSSM
• Identify and drive enhancements/standardization of CSSM TA deliverables and tolls/processes to increase efficiencies
• Provide leadership during conduct of risk assessments and mitigation planning for priority program execution
• Ensure the successful execution for all headquarter based patient clinical trials

Executive Director, Clinical Operations, Oncology

• Prepare, analyze, negotiate, and execute required site agreements and associated budgets
• Perform quality control checks of agreements prior to execution
• Lead and develop relationships with key investigational sites and Site Management Organizations across the contracting and budgeting interface
• Contribute to the development of local SOPs
• Act as process Subject Matter Expert (SME)

Clinical Operations Manager – Finance

• Manages, analyzes and coordinates the daily activities of the unit to ensure departmental productive goals are met with regards to quality timeliness, accuracy and consistency of medical decisions
• Ensures staff meets all regulatory requirements and comprehends and complies with best practices, professional standards, internal policies and procedures
• Conducts continuous evaluation of workflows and seeks to improve processes that impact the department
• Coordinates data collection, reviews compliance reporting and identifies opportunities for improvements
• Identifies and implements cost saving/revenue generating opportunities
• Serves as key liaison between Medical Directors, Management leadership, and staff
• Develops key performance indicators to evaluate level of service for internal and external customers
• Acts as a subject matter expert for difficult and complex matters
• Represents the Plan with external customers, providers and agencies
• Represents the department on internal committees and participates in special projects
• Assists Manager in coordinating regulatory, quality and accreditation activities
• Performs other duties as assigned by management
• Creates and champions an atmosphere within the team, which fosters open communication, teamwork, ownership, and a collaborative cross-departmental environment to implement, optimize and share continuous improvement processes
• Manages, directs, and develops staff by providing feedback and coaching
• Administers performance and salary reviews for staff
• Assists in preparing and monitoring the budget to ensure administrative cost objectives are met

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