Senior Clinical Program Manager

🕒 vor 15 Tagen

🇺🇸 Vereinigte Staaten – Remote

💵 $160.000 - $190.000 / Jahr

⏰ Vollzeit

🟠 Senior

🏥 Manager Klinischer Studien

🦅 H1B-Visum-Sponsor

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🗣️🇺🇸🇬🇧 Englisch erforderlich

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LivaNova

1001 - 5000 Mitarbeiter

🏭 Fertigung

🏥 Gesundheitswesen

🧬 Biotechnologie

Manufacturing • Healthcare • Biotechnology

LivaNova PLC ist ein globales Medizintechnikunternehmen, das auf nahezu fünf Jahrzehnten Erfahrung und dem unermüdlichen Engagement basiert, das Leben von Patientinnen und Patienten weltweit zu verbessern. Unsere fortschrittlichen Technologien und bahnbrechenden Therapien bieten wirkungsvolle Lösungen zum Nutzen von Patientinnen und Patienten, medizinischem Fachpersonal und Gesundheitssystemen.

Beschreibung

• Provide overall clinical project management direction, prioritization, and ensure global study objectives are delivered on time and within budget. • Lead a clinical operations team managing multiple studies aligned with key business strategies. • Work closely with study managers, support teams, and monitors to ensure high-quality studies. • Provide cross-functional input to development programs and deliver study status updates and responses to Marketing, Regulatory, R&D, Market Access, Medical Affairs, and PMO teams. • Support the Clinical Operations Director in achieving study goals and oversee program/study-level outsourcing. • Take proactive corrective actions to address study and program issues. • Drive continuous process improvement by identifying operational gaps and implementing optimized clinical operations solutions. • Lead strategic initiatives enhancing efficiency, transparency, quality, and compliance across clinical programs and departmental workflows. • Apply critical thinking and scientific rigor to the design and review of clinical study protocols. • Manage multiple cross-functional clinical project teams across the clinical portfolio. • Ensure studies follow ethical, regulatory, and GCP standards. • Assess the assigned study portfolio within 30 days, identify critical actions, and implement appropriate plans. • Interface with Clinical Science, the medical community, internal and external stakeholders, and the Clinical Operations Director to address clinical and regulatory needs. • Identify study and program risks and develop mitigation strategies. • Set study activity priorities with Operations, Monitoring, and Data Management teams. • Ensure communication with global stakeholders. • Manage delivery of multicenter global clinical studies to required inclusion rates, timelines, and budgets. • Communicate program updates and results to internal and external stakeholders. • Assist in developing and issuing corporate-wide dashboards for major initiatives. • Provide expert input during STC meetings and support study-related decision-making. • Offer clinical insights to Product Development teams and integrate clinical considerations into product strategy, innovation planning, and lifecycle management. • Support long-term clinical strategies and prioritization of studies, publications, and evidence-generation needs. • Mentor, train, and assist project managers on protocol development and project management methodologies, tools, and techniques. • Create business cases supporting informed strategic decisions. • Train and mentor staff in clinical practice, project management principles, methodologies, and procedures.

🎯 Anforderungen

• Minimum 8 years clinical project/program management experience in a medical device environment with demonstrated consistent professional advancement. • Strong project management skills. • Ability to convert strategic plans to prioritized product, development and/or operational business objectives. • Strong written, verbal, and interpersonal communication skills; a writing sample will be required from top candidates. • Ability to troubleshoot and make appropriate decisions under pressure and handle multiple meetings at one time. • Exceptional organizational skills. • High aptitude for MS Office applications: Outlook, Word, Excel, and PowerPoint. • Experience working in a fast-paced, complex, dynamic, multi-cultural business environment. • Ability to build and maintain effective relationships with internal and external contacts. • Ability to work independently and in a group environment. • Ability to establish and maintain effective working relationships with others. • Fluent in English. • An additional European language is an asset. • Bachelor’s degree in a scientific field or equivalent working experience. • Regular business travel of 35% or more of the time.

🏖️ Vorteile

• Health benefits – Medical, Dental, Vision • Personal and Vacation Time • Retirement & Savings Plan (401K) • Employee Stock Purchase Plan • Training & Education Assistance • Bonus Referral Program • Service Awards • Employee Recognition Program • Flexible Work Schedules • Discretionary annual bonus

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