Vice President, Clinical Operations

Sitero LLC
  • Raleigh, NC
    16 days ago

    Job Description

    Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation.

    The Vice President, Clinical Operations is a strategic and operational leader responsible for the global execution, quality, and scalability of Sitero's clinical services portfolio. This role sits at the intersection of clinical delivery, technology enablement, and innovation-driving excellence across traditional clinical operations while leveraging Sitero's eClinical solutions and emerging AI capabilities to enhance speed, quality, and client outcomes.

    As Sitero continues to expand its footprint across clinical services and technology-enabled delivery, the VP, Clinical Operations will play a pivotal role in shaping operational strategy, strengthening delivery infrastructure, and ensuring consistent, high-quality execution across all programs. This individual will partner closely with executive leadership, Product, and Commercial teams to deliver integrated solutions that differentiate Sitero in a competitive CRO landscape.

    Job Title: Vice President, Clinical Operations Location: Eastern US Based Function: Clinical Services

    ESSENTIAL DUTIES AND RESPONSIBILITIES:

    Define and execute a global clinical operations strategy aligned with Sitero's growth objectives, client expectations, and integrated service delivery model Lead and scale global clinical operations teams, ensuring organizational structure, talent, and capabilities support both current delivery and future expansion Drive operational excellence across all clinical programs, with a focus on quality, speed, and consistency in execution Oversee the full lifecycle of clinical trials-from study startup through closeout-ensuring delivery on time, within scope and budget, and in compliance with ICH-GCP, FDA, EMA, and other applicable regulations Establish and monitor KPIs, performance metrics, and dashboards to provide visibility into delivery performance, risks, and opportunities Optimize resource planning and utilization globally, partnering with Finance and HR to align workforce strategy with pipeline demand and margin objectives Embed quality-by-design principles into clinical operations, partnering closely with Quality Assurance to address audit findings, CAPAs, and continuous improvement initiatives Ensure SOPs, processes, and governance frameworks are consistently implemented and evolve alongside regulatory and business needs Serve as an executive point of contact for key clients, strengthening relationships and ensuring delivery excellence across strategic accounts Partner with Business Development and Commercial teams on proposals, bid defenses, and client presentations, ensuring operational feasibility and competitive positioning Collaborate closely with eClinical Service Delivery and Product teams to integrate technology solutions into clinical operations, enhancing efficiency, data quality, and user experience Champion the adoption of AI-driven tools and analytics to improve trial execution, forecasting, risk identification, and decision-making Lead cross-functional alignment across Medical Affairs, Regulatory, Data Management, Biostatistics, Product Management, and Quality to ensure seamless program execution Build and develop a high-performing leadership team, fostering a culture of accountability, ownership, and continuous improvement in line with #WeareSITERO values Establish clear career pathways, training frameworks, and succession planning for clinical operations talent globally Own clinical operations financial performance, including budget oversight, forecasting, revenue realization, and margin optimization Contribute to enterprise-wide strategic initiatives, including operational scaling, global expansion, and M&A integration efforts

    EDUCATION AND EXPERIENCE REQUIRED:

    Bachelor's degree in Life Sciences or related field; advanced degree (MS, MPH, MBA) preferred 15+ years of progressive clinical operations leadership experience within a CRO, biotech, or pharmaceutical environment Demonstrated experience leading global, multi-functional clinical operations teams across multiple regions (US, EMEA, APAC/India preferred) Proven track record of delivering complex clinical programs at scale, with strong knowledge of regulatory requirements and industry best practices Experience integrating technology and/or eClinical platforms into clinical delivery models; exposure to AI-enabled solutions is a strong advantage Strong financial acumen with experience managing budgets, forecasting, and operational P&L drivers Experience supporting business development efforts, including proposals, bid defenses, and client relationship management Exceptional leadership, communication, and stakeholder management skills, with the ability to influence at the executive level Ability to operate effectively in a high-growth, fast-paced, and evolving organization

    COMPENSATION & BENEFITS: Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, paid time off, and healthcare and retirement benefits.

    EMPLOYMENT TYPE: Full Time, Permanent

    COMMITMENTS:

    Standard Hours 40 hours per week, one hour lunch, Monday - Friday. Additional hours as needed. Willing to work in shifts as and when needed.

    DISCLAIMER: Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

    Numbers & Facts

    LocationRaleigh, NC

    Skills

    • Artificial Intelligence (AI)unmatched
    • Best Practicesunmatched
    • Biologyunmatched
    • Biostatisticsunmatched
    • Biotech and Pharmaceuticalunmatched
    • Budget Managementunmatched
    • Business Administrationunmatched
    • Business Developmentunmatched
    • Channel Strategiesunmatched
    • Clinical Information Systemsunmatched
    • Clinical Medicineunmatched
    • Clinical Practices/Protocolsunmatched
    • Clinical Researchunmatched
    • Clinical Trialunmatched
    • Continuous Improvementunmatched
    • Contract Research Organization (CRO)unmatched
    • Cross-Functionalunmatched
    • Customer Relationsunmatched
    • Customer Relationship Management (CRM)unmatched
    • Data Managementunmatched
    • Data Qualityunmatched
    • Device Driversunmatched
    • FDA (Food and Drug Administration)unmatched
    • Financeunmatched
    • Forecastingunmatched
    • GCP (Good Clinical Practices)unmatched
    • ICH Regulationsunmatched
    • Leadershipunmatched
    • Medical Affairsunmatched
    • Mergers and Acquisitionsunmatched
    • Monitor Regulationsunmatched
    • Operational Strategyunmatched
    • Operations Planningunmatched
    • Performance Analysisunmatched
    • Performance Metricsunmatched
    • Phase III Clinical Trialsunmatched
    • Product Managementunmatched
    • Product Positioningunmatched
    • Profit & Lossunmatched
    • Quality Assuranceunmatched
    • Regulationsunmatched
    • Regulatory Requirementsunmatched
    • Reporting Dashboardsunmatched
    • Resource Utilizationunmatched
    • Revenue Forecastingunmatched
    • Risk Analysisunmatched
    • Safety/Work Safetyunmatched
    • Sales Presentationunmatched
    • Service Deliveryunmatched
    • Standard Operating Procedures (SOP)unmatched
    • Startupunmatched
    • Strategic Accountsunmatched
    • Strategic Planningunmatched
    • Succession Planningunmatched
    • Technical Deliveryunmatched
    • Time Managementunmatched
    • User Interface/Experience (UI/UX)unmatched

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