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Associate director - clinical operations

Philips
Director
Inserat online seit: 23 November
Beschreibung

Job Title Associate Director - Clinical Operations Job Description As an important member of our talented Hospital Patient Monitoring (HPM) Clinical Affairs team, the Associate Director- Clinical Operations, is responsible for day-to-day Clinical Operations/team Management and providing expertise in clinical research process legislation, ICH-GCP guidelines, improving efficiency in clinical execution. Your role: Responsible for planning, direction, and coordination of clinical programs and activities, including overseeing Clinical Evidence planning and generation, Clinical PIL tools, process implementation, ensuring compliance with applicable laws, regulations, and standards. Ensures accountability for process execution, system functionality, backlog management, and improvement initiatives. Assists in the updates and enhancement of quality system processes for Clinical & Medical Affairs, aligning with business strategies, roadmaps, and Informatics demands. Serves as a primary point of contact between Clinical & Medical Affairs and other departments, driving cross-function cooperation and ensuring stakeholder alignment. Coordinates change requests and submissions, ensuring all critical parties are aligned and changes are effectively implemented. Works with a diverse global team, emphasizing project management, business analysis, service management, solution ownership, and validation to achieve targeted outcomes. Promotes application standardization through shared processes, data harmonization, and architectural compliance, while fostering strong relationships. Leverages expertise in Clinical & Medical Affairs to propose innovative ideas that support the function meeting their objectives. Ensures compliance with training requirements and driving continuous improvement for the clinical programs. Supports the development of the Clinical & Medical Affairs team by sharing resources, knowledge, and experience, and leading initiatives that enhance the organization. You should bring the following: You have a minimum of a Bachelors’ Degree (Required) in Biology, Health Science MPH, Nursing or equivalent. Master’s/PhD desired. Six Sigma, Safe, Agile, PMP certifications desired.You have a minimum of 10 years’ Clinical Operations experience within Medical Device Clinical Research and FDA regulated OEM Medical Device product environments. Experience in Patient Monitoring (desired). You have a minimum of 3 years’ experience in functional management of Clinical teams, including budgeting, training, staff development, performance management, resource management (overseeing the allocation of personnel, materials, and other resources to meet project or organizational goals), continuous improvement, etc. You have proven expertise in leading Clinical Operations, execution, research process legislation, ICH-GCP guidelines, planning and associated technologies/tools. You have a detailed understanding of Clinical & Medical Affairs, leveraging expertise to propose innovative ideas, providing meaningful input and contribute to senior leadership discussions. You have a deep understanding of Health Care Research methodology, regulations, laws, and guidance in major markets such as EU, USA, UK, AUS, Japan and China. You have proven experience in building/Cultivating strong working relationships and partnerships with business stakeholders/functions and influencing internal/external service providers towards achieving strategic objectives. Philips benefits for you: Annual leave: 30 days Mobility and devices: subsidized Germany ticket (instead of 58€ only 35,10€), leasing opportunities for private use (bicycles, cars, smartphones,…) Philips University & Philips in Balance: Wide range of professional training courses and for personal development & Healthcare Philips Pension Fund: Employer-funded pension plan “Partnerzeit” – two paid weeks off after your partner has given birth Philips MyShop: Discount on Philips products Meals: Free drinks and low prices in our canteen and Café Philistro Culture: Informal culture, a paid day for voluntary work, various team/cultural activities (on sustainability, diversity, ), etc. How We Work Together We believe that we achieve better results when we work together rather than apart. For this role this means to be on-site at least 3 days a week. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. With patient safety and Quality as our fundamental premise, we focus on regulatory requirements and quality standards in our daily work. Do the work of your life to help the lives of others. Learn more about our business. Discover our rich and exciting history. Learn more about our purpose. If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here. Optional: LI-OFFICE

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