Increasing demand for observational research and real-world evidence (RWE) from regulatory and reimbursement authorities makes observational research a critical component of drug development and commercialization.
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The CfOR Strategic Planning & Operations Manager drives operational excellence, strategic execution, workforce planning, study operations, analytics, and digital transformation across the organization.
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This role requires expertise in business operations, study management, data analytics, dashboarding, forecasting, process optimization, and digital enablement.
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The ideal candidate is analytical, execution-oriented, and capable of translating complex operational data into actionable leadership insights using tools such as Power BI.
Strategic Planning & Business Operations
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Partner closely with CfOR leadership to support strategic planning, operational execution, workforce planning, and organizational initiatives.
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Drive cross-functional operational programs and strategic initiatives across global teams, ensuring alignment with organizational goals and priorities.
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Support leadership decision-making through business analysis, operational insights, scenario planning, and executive-ready presentations.
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Manage and track organizational priorities, risks, dependencies, timelines, and action plans across multiple workstreams.
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Support headcount management, staffing analysis, requisition tracking, organizational planning, resource forecasting, and capacity planning.
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Support operational budgeting, financial tracking, forecasting, and resource planning activities across organizational initiatives and study operations.
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Analyze resource utilization, portfolio demand, operational capacity, and forecasting trends to support leadership planning and prioritization decisions.
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Lead operational transformation initiatives and strategic special projects.
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Support organizational governance activities including leadership reviews, operational planning cadences, hiring alignment, and cross-functional coordination.
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Drive operational readiness initiatives across teams by improving visibility into resource capacity, prioritization, and execution tracking.
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Partner with functional leaders to streamline onboarding, collaboration models, knowledge management, and operational communication frameworks.
Data Analytics, Reporting & Visualization
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Develop and maintain executive dashboards, operational metrics, KPIs, and reporting frameworks using Power BI and other visualization tools.
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Translate operational, organizational, and portfolio data into actionable insights for senior leadership.
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Analyze trends across resource allocation, study delivery, operational efficiency, financials, forecasting, and portfolio performance to support strategic decisions.
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Build scalable reporting solutions that improve visibility, transparency, and operational governance across CfOR.
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Partner with stakeholders to define reporting standards, business requirements, and performance measurement frameworks.
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Develop integrated reporting solutions, forecasting models, and self-service dashboards across multiple operational data sources.
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Drive data quality, reporting consistency, process standardization, and governance across operational systems.
Study, Project & Program Management
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Lead operational planning, coordination, and execution of observational research studies and cross-functional operational initiatives.
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Partner with study teams, functional stakeholders, and vendors to support study timelines, deliverables, operational readiness, and execution tracking.
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Support end-to-end study operations including planning, governance, resource coordination, risk tracking, issue resolution, and stakeholder communication.
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Develop and maintain project plans, roadmaps, RAID logs, governance trackers, and operational documentation.
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Facilitate cross-functional meetings, manage dependencies, and ensure timely completion of operational and study-related milestones.
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Monitor portfolio progress, operational risks, execution metrics, and forecasting trends to support proactive decision-making.
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Communicate project and study status, risks, escalations, and key updates effectively to stakeholders and leadership.
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Support vendor coordination, budget tracking, financial monitoring, forecasting activities, and resource management.
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Operate effectively in fast-paced, matrixed environments with evolving priorities and competing business needs.
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Observational studies related compliance responsibilities & governance with understanding of Veeva vault, regulatory information management, inspection and submission Readiness.
Digital Transformation & Operational Excellence
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Lead adoption and optimization of digital collaboration and workflow tools including Microsoft Teams, SharePoint, Miro, and Power Platform solutions.
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Support SharePoint governance, content organization, operational documentation, and knowledge management initiatives across teams.
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Evaluate and implement modern workflow management and collaboration tools that improve operational scalability and team effectiveness.
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Identify opportunities to improve operational processes through automation, standardization, and digital enablement.
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Leverage AI and productivity tools such as Microsoft Copilot, ChatGPT, and AI agents to streamline workflows, documentation, communications, reporting, and meeting management.
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Support experimentation and implementation of emerging technologies that enhance organizational efficiency and stakeholder engagement.
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Drive continuous improvement initiatives focused on scalability, operational maturity, and user experience.
Stakeholder Management & Communication
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Build strong collaborative relationships across CfOR, study teams, functional partners, and enterprise stakeholders.
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Influence stakeholders across varying levels of the organization through structured problem-solving, operational leadership, and data-driven recommendations.
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Prepare executive communications, dashboards, presentations, operational summaries, leadership business reviews, and forecasting updates.
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Facilitate alignment across geographically distributed teams through structured communication, governance processes, and operational planning.
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Act as a trusted strategic operations partner capable of balancing organizational priorities with tactical execution.
Preferred Qualifications
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8–10+ years of experience in strategic operations, program management, business operations, analytics, or related roles within pharma, biotech, healthcare, consulting, or regulated industries.
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Strong expertise in Power BI, dashboard development, data visualization, operational analytics, and reporting automation.
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Advanced proficiency in Microsoft Excel, PowerPoint, Power BI, Microsoft O365, SharePoint, and modern workflow/project management platforms.
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Experience supporting operational management of observational research studies or cross-functional healthcare/pharma initiatives preferred.
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Experience building executive-level dashboards and presenting operational insights to senior leadership teams.
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Strong analytical and problem-solving skills with the ability to synthesize large datasets into actionable recommendations.
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Proven ability to manage complex cross-functional projects in fast-paced, matrixed environments.
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Experience with Agile methodologies including SAFe, Scrum, and Kanban.
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Demonstrated ability to improve operational efficiency through automation, process optimization, and digital transformation initiatives.
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Familiarity with Power Platform tools (Power Automate, Power Apps) and workflow automation solutions preferred.
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Working knowledge of AI productivity tools such as Microsoft Copilot, ChatGPT, AI agents, and other emerging digital solutions.
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Strong communication and stakeholder management skills with the ability to influence across organizational levels.
Experience with operational budgeting, portfolio forecasting, capacity planning, and business planning support preferred.
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Experience building scalable operational processes, governance frameworks, and executive reporting models in matrixed organizations preferred.
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Understanding of pharmaceutical development, real-world evidence, clinical operations, or healthcare business environments preferred.
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Knowledge of GxP, regulatory, and compliance environments is a plus with understanding of Veeva vault, regulatory information management, inspection and submission Readiness.
Key Success Attributes
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Strategic thinker with strong operational execution capabilities.
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Highly data-driven with strong business acumen.
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Comfortable balancing strategy, analytics, operations, and execution.
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Strong ownership mindset with ability to independently lead initiatives.
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Collaborative and relationship-oriented with excellent communication skills.
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Passion for innovation, continuous improvement, and leveraging technology to drive efficiency.
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Adaptable, agile, and capable of thriving in rapidly evolving environments.