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

• manage the implementation and installation of diagnostic instrumentation portfolio
• coordinate with laboratory customers, hospital facilities teams, IT stakeholders
• provide quality implementations with updates to Project Teams and Stakeholders
• act as the single point of contact between the customer and BCI
• maintain all project related documentation

Project Manager, Clinical Lab Equipment Installation

• Organizes and participates in Monitor’s and Investigator’s Meetings.
• Performs, if necessary, co-monitoring visits for the assigned clinical projects.
• Carries out, after appropriate and documented training/past experiences, the monitoring of the sites for the assigned projects, when requested and if applicable.
• May act as Feasibility Associate (FEA) after appropriate and documented training.
• Review and approve third party invoices for payment. Review and approve contractor timesheets for alliance with agreed scope of work.
• Develop and implement alternative solutions to problems with study timelines, resources, budgets, etc.
• Ensure issues are identified and communicated by the study team. Implement corrective action plan to prevent repetition of critical issues.
• Assess scope of work and timelines against contractual agreements and identify change orders pro-actively.
• Manage any deviations on resources and hours spent on the project to be able to evaluate the project progress and profitability and identify change orders in a timely manner and implement corrective actions. Ensure budget discrepancies are documented.
• Submit invoice requests, trial related invoices and payment authorizations to finance in a timely manner.
• Regularly track all expenditure and review for consistency with trial budgets.
• Organize quality check of filing of key study documentation.
• Ensure all administrative close-out procedures are completed.
• Follow and comply with the Company’s QMS, ISMS and PIMS requirements.

Clinical Project Manager II

• 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

• Leads state level quality strategy meetings
• Develops a quality plan, and ensures integration of quality into the overall business process
• Works with the clinical intervention team to design studies to identify barriers to medical interventions
• Ensures that study methodology is sound and appropriate reporting is in place
• Develops performance improvement plans and oversees the clinical quality improvement activities/projects to improve the quality of care for members
• Assures compliance with corporate QI work plans
• Assures that all QI activities are relevant to the needs of targeted population
• Maintains effective documentation of research programs to meet regulatory and Accreditation Standards
• Provides oversight to assure accurate and complete quantitative analysis of clinical data and presentation of data analysis results
• Participates in and provides input to the development of new product designs for major line of business
• Oversees the implementation of new initiatives
• Leads interactions with regulators or oversight entities
• Oversees quality improvement activities for the largest, most complex state programs

Clinical Quality Program Manager

• Develop and execute accurate operational development plans for assigned clinical trials, aligning with budget, timelines, and standard operating procedures (SOPs)
• Oversee the management of clinical studies, including compliance with corporate, regulatory, and quality standards.
• Lead clinical operations personnel, contract research organizations (CROs), consultants, core laboratories, and other study support organizations.
• Handle program-level activities as assigned, ensuring operational plans are implemented effectively.
• Ensure adherence to ICH-GCP, GPP, Incyte SOPs, and applicable country-specific regulations.
• Work cross-functionally with internal teams (e.g., Medical Affairs, Medical Science Liaisons, Medical) and external partners to support trial goals and timelines.
• Monitor site performance, feasibility, and study execution for assigned trials.

Senior Director, 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

• Leading and executing complex clinical trial contracts and budget negotiations with investigative sites, CROs and vendors
• Partnering with Clinical Operations leadership to develop and deliver contracting and budgeting strategies across programs and portfolios
• Providing strategic input into study feasibility, start-up planning, and early budget development
• Ensuring contracts and budgets comply with company policies, regulatory standards, and regional requirements
• Collaborating closely with Clinical Operations, Finance, Legal, and study teams to drive timely execution and approvals
• Identifying financial, operational and regional risks and proactively proposing mitigation strategies
• Tracking contract and budget performance, reporting trends and key metrics
• Driving continuous improvement initiatives to enhance efficiency, consistency, and best practices
• Acting as a subject matter expert on contract templates, budget models, and industry standards

Senior Specialist, Clinical Operations – Contracting & Budgeting

• 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

• Developing and managing detailed project plans, including timelines, budgets, and resource allocation to ensure successful project delivery.
• Leading cross-functional project teams, coordinating efforts to meet project objectives, and facilitating effective communication and collaboration.
• Monitoring project progress, identifying potential risks and issues, and implementing strategies to address challenges and keep projects on track.
• Engaging with stakeholders to manage expectations, provide updates, and ensure alignment with project goals and organizational objectives.
• Preparing and presenting project reports, status updates, and performance metrics to senior management and other stakeholders.

Senior Manager, Clinical Operations

• 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

Clinical Operations jobs in Pennsylvania

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Manager, Clinical Operations

Project Manager, Clinical Lab Equipment Installation

Clinical Project Manager II

Technical Product Owner, Clinical Operations Technology

Senior Manager, Product Group Engineer, Clinical Operations

Technical Product Owner, Clinical Operations Technology

Clinical Quality Program Manager

Senior Director, Clinical Operations

Senior Director, Clinical Operations – Portfolio & Resource Operations

Senior Specialist, Clinical Operations – Contracting & Budgeting

Senior Clinical Project Manager, Analyst

Senior Clinical Project Manager

Senior Manager, Clinical Operations

Scientist, Clinical Operations

Clinical Operations Scientist

Senior Scientist, Clinical Operations

Associate Principal Scientist, Clinical Operations