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

• Leading global cross-functional project team delivery
• Serving as the primary contact with the customer for progress and governance
• Developing study management plans
• Anticipating risk and implementing mitigation strategies
• Managing study budget proactively

Clinical Program Manager

• Own vision, priorities, and near-term roadmap for participant data collection capabilities in alignment with Clinical Operations objectives, business impact, and study delivery needs.
• Shape and prioritize the squad backlog by translating Clinical Operations needs, study process requirements, and customer insights into clear user stories and acceptance criteria.
• Balance business value, customer experience, and technical feasibility while prioritizing features, enhancements, fixes, and release content.
• Act as the voice of the customer within the squad to help ensure solutions meet user needs across Clinical Operations, study teams, sites, and participant-facing processes.
• Work closely with engineering, UX, data management, privacy, security, quality, and compliance stakeholders throughout the product lifecycle.
• Facilitate release planning, sprint planning, reviews, demos, and synchronization with dependent teams to support delivery across cross-squad and operational workflows.
• Track squad-level metrics and operational results to provide visibility into adoption, delivery performance, data quality, and user outcomes.
• Work with the Lead Engineer to assess solution options, support user testing readiness, and balance technical debt with feature delivery.
• Support communications, training, documentation, and stakeholder engagement to improve adoption, clarity on roadmap activities, and release readiness.
• Actively participate in squad ceremonies and continuous improvement activities to help optimize the flow of value and delivery efficiency.

Technical Product Owner, Clinical Operations Technology

• Lead and develop a high-performing team supporting Clinical Operations technology while translating business priorities into practical, compliant, and scalable digital solutions.
• Manage, coach, and develop a team of technical professionals delivering solutions that enable Clinical Operations processes and strategic priorities.
• Partner with Clinical Operations business stakeholders to understand priorities, shape roadmaps, and convert business needs into actionable delivery plans.
• Balance business outcomes, user experience, technical feasibility, compliance requirements, and resource capacity when making delivery decisions.
• Lead planning and prioritization across the team backlog, ensuring work aligns with product strategy, architecture, and Clinical Operations objectives.
• Drive cross-functional alignment across business, product, quality, and engineering teams to ensure solutions are fit for purpose and sustainable over time.
• Ensure the team delivers secure, reliable, and validated solutions that support Clinical Operations workflows, data integrity, and inspection readiness.
• Provide oversight for solution design, systems integration, release readiness, and operational support in a regulated environment.
• Foster strong partnerships with vendor and platform teams to deliver integrated capabilities across the clinical technology landscape.
• Build a team culture grounded in accountability, continuous improvement, collaboration, and patient-focused outcomes.
• Participate in governance, planning, and business review forums to communicate delivery progress, risks, dependencies, and investment needs.
• Use data, feedback, and operational insight to continuously improve team performance, delivery quality, and platform value.
• Resolve delivery risks, technical issues, and cross-team dependencies while maintaining focus on business value and team effectiveness.
• Support workforce planning, hiring, onboarding, and talent development to build long-term capability within the organization.
• Guide investment and prioritization decisions by assessing business impact, technical complexity, compliance considerations, and support needs.
• Collaborate with enterprise and platform teams to identify reusable capabilities, standardize processes, and reduce unnecessary complexity.
• Translate complex technical concepts into clear options and recommendations for business stakeholders and senior leaders.
• Promote pragmatic innovation that advances Clinical Operations capabilities while maintaining operational stability and compliance.
• Manage development and review cadence at the Product Group Level, align tech landscape and roadmap across Products to promote reusability, scalability and modularity.
• Observe trends across the industry and conduct research spikes for new capability and innovation/technology adoption opportunities.
• Coach and mentor team members and drive continuous improvement, technical standards (e.g., frameworks, architecture) and best practices implementation (e.g., reusable, scalable and modularized architecture).

Senior Manager, Product Group Engineer, Clinical Operations

• Provides Portfolio and Resource operations leadership and direction across the GDMS organization
• In partnership with the GDMS functional areas, leads the definition of operational processes, governance frameworks, and forecasting methodologies
• Monitors and provides operations oversight to ensure consistent execution, quality, and compliance with established GDMS business operations processes
• Represents GDMS at Portfolio and Resource Operations enterprise forums
• Ensures strategic alignment of GDMS Portfolio and Resource Operations with Global Clinical Trial Operations (GCTO), Global Clinical Data Operations (GDO) and our research division's Portfolio & Resource Operations (PROS) functions
• Leads the coordination of strategic GDMS productivity and operating model initiatives; tracks progress against established commitments; and ensures alignment with GDMS and broader organizational priorities
• Champions organizational change strategy; drives adoption of new operating models and digital capabilities.
• Oversees capacity modeling, forecasting methodologies, and works proactively across GDMS functional areas and business partners to manage risks aligned with business, financial, and operational objectives
• Coordinates GDMS budget forecasting and monitors expenses against financial targets
• Coordinates, tracks, and drives outcomes pertaining to GDMS objectives, KPIs, and KQIs in partnership with GDMS functional areas and business partners
• Defines strategically and operationally relevant GDMS performance and quality indicators; facilitates operations reviews; and aligns GDMS metrics with broader GCTO control towers for visibility
• Establishes and monitors compliance with change control procedures for core GDMS operational processes

Senior Director, Clinical Operations – Portfolio & Resource Operations

• Develops and authors clinical research protocols
• Manages essential study documents
• Supports approvals and leads final study reporting and closeout activities
• Trains and manages CRA teams
• Leads budget and timeline development
• Oversees site selection and training
• Works closely with clinical data management and biostatistics teams

Clinical Project Manager

• Serve as the primary clinical consultant for assigned hospital and health system clients.
• Build and maintain strong relationships with client leadership, including Case Management Directors, Revenue Cycle Leaders, Physician Advisors, and C-suite executives.
• Conduct assessments of utilization review processes and identify opportunities for operational improvement.
• Provide strategic recommendations to improve authorization processes, reduce denials, and optimize reimbursement.
• Facilitate client meetings, present findings, and communicate project updates to stakeholders.
• Support implementation of process improvements and monitor performance metrics.
• Review inpatient and outpatient utilization management processes for compliance and efficiency.
• Analyze denial trends, payer behavior, and utilization patterns.
• Collaborate with physician advisors and operational teams to improve medical necessity documentation and appeal success rates.
• Provide guidance on CMS, Medicare, Medicaid, and commercial payer requirements.
• Assist clients with length-of-stay management, authorization processes, and denial prevention strategies.
• Develop and implement best practices related to utilization management and revenue integrity.
• Educate client teams on regulatory changes, payer requirements, and industry best practices.
• Develop training materials, workflows, and standard operating procedures.
• Mentor and support internal consultants and clinical team members.
• Serve as a subject matter expert during client engagements and business development opportunities.

Clinical Operations Lead

• Update and maintain clinical systems within project timelines and review files for accuracy and completeness
• Support the Clinical Operations team with ongoing conduct of studies including specific allocated study management tasks as defined by the Clinical Trial Manager (CTM)
• Support inspection readiness
• Prepare, handle and distribute of Clinical Trial materials and maintenance of tracking information
• Act as a central contact for the clinical team for designated project communications
• Schedule Project related meetings, attend operational team meetings, write and/or review meeting minutes, distribute minutes and follow-up actions
• Assist with preparation of meeting materials, presentations
• Prepare, handle, distribute, file and archive clinical documentation and reports according to standard operating procedures
• Assist with identification of potential clinical sites; maintain investigator lists
• Support organization of investigator meetings/advisory boards
• Review of study files periodically for accuracy and completeness
• Track and manage Case Report Forms (CRFs), queries and clinical data flow
• Utilize JDE system to monitor funds on existing purchase
• Manage tracking of all Clinical operations contracts generated (i.e. coding, approvals, filing, etc.) and associated invoices
• Other duties as assigned

Contract - Clinical Trial Associate, 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).

• 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

• Lead the planning, execution, and delivery of medium to large, multi-regional clinical studies.
• Develop and implement integrated study management plans.
• Serve as the primary liaison with sponsors.
• Set direction and objectives for cross-functional project teams.
• Partner with Business Development on bid defenses.
• Proactively identify, assess, and mitigate risks.
• Monitor project progress against timelines, budget, and quality metrics.
• Ensure financial performance by managing budgets.

Senior Clinical Project Manager

• Working within the Medical Affairs organization, the Senior Clinical Project Manager (Specimen Management) is responsible for clinical trial management of multiple studies and may be subject matter authority for group or platform of assigned clinical studies including the planning, implementation, oversight, project management and completion of clinical trials conducted by Medical Affairs or Contract Research Organizations (CRO).
• The Senior Clinical Project Manager may also serve as mentor to other Clinical Project Managers.
• This role serves as the project lead for multiple studies of high complexity from protocol development through study conduct and closeout in compliance with Good Clinical Practices, and all Global, National and Local Regulations.
• Reports to and collaborates with Clinical Portfolio Management to review business requests and evaluate or develop early plans and concepts for optimal study execution.
• Works without appreciable supervision and direction, prepares and/or reviews study-related or essential study start-up documents as they relate to the assigned clinical trials (e.g., Clinical Protocols, Informed Consent forms, Monitoring Plan, Clinical Product Management Plan, Clinical Safety Management Plan, Case Report Form (CRFs), CRF Completion Guidelines and other relevant documents).
• Serves as a Clinical Project Manager ensuring that the Study Management team meets or exceeds the timelines and deliverables assigned to the study team.
• Oversees/leads study-specific study management resources.
• Develops and manages group of studies for an entire business unit or large development program.
• Mentors other Clinical Project Managers.
• Provides critical thinking and leadership when issues arise during execution of clinical studies.
• Writes protocols, clinical study reports and other clinical study deliverables as applicable.
• Leads or gives to continuous improvement activities/initiatives.
• Handles relationships with sites/PIs, other study related vendors, including CROs.
• Intermediate knowledge, of established project management standards used to develop and maintain integrated project plans (scope/work packages, time/schedule, cost/material and human resources, quality, communication/escalation, risk, value) and organizes/facilitates meetings and discussions as needed.
• Defines, tracks and reports schedule attributes such as durations, interdependencies, achievements, critical path and other key deliverables including efficiency and effectiveness of plans and staff.
• Adapts work package deliverables based on study scale and complexity.
• Creates bold but achievable resource and budget forecasts and timelines.
• Interacts with both Internal and External representatives, providing direction to the cross functional team members and vendors (if applicable) regarding the technical, protocol-specific and operational aspects of assigned studies.
• Proactively identifies and manages risks and issues (including a log, mitigations, and contingencies) to ensure cost-effective and timely delivery of the project including critical issues if needed.
• Plans and maintains high quality standards to meet compliance requirements. All other duties as assigned.

Senior Clinical Project Manager, Specimen Management

• 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.

• 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.

Clinical Operations jobs in New Jersey

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Manager, Clinical Operations

Clinical Program Manager

Technical Product Owner, Clinical Operations Technology

Senior Manager, Product Group Engineer, Clinical Operations

Technical Product Owner, Clinical Operations Technology

Senior Director, Clinical Operations – Portfolio & Resource Operations

Clinical Project Manager

Clinical Operations Lead

Contract - Clinical Trial Associate, Clinical Operations

Clinical Program Manager

Director, Clinical Operations

Senior Clinical Project Manager

Senior Clinical Project Manager, Specimen Management

Clinical Project Manager

Senior Clinical Project Manager, Analyst

Senior Clinical Project Manager

Clinical Operations Project Lead

Scientist, Clinical Operations

Clinical Operations Scientist

Senior Scientist, Clinical Operations