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Senior manager clinical development - patient monitoring

Böblingen
Philips
Senior Manager
Inserat online seit: Veröffentlicht vor 2 Std.
Beschreibung

JOB DESCRIPTION

Job Title

Senior Manager Clinical Development - Patient Monitoring

Job Description

As an important member of our talented Hospital Patient Monitoring (HPM) Clinical Affairs, the Senior Manager-Clinical Development is responsible for managing the day-to-day operations of Clinical Measurements & Specialty Monitoring clinical programs, improving efficiency and simplifying the planning/execution of clinical plans. This role can be based either in Boblingen (Germany) or in Eindhoven (Netherlands)

Your role:

1. 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.

2. Ensures accountability for process execution, system functionality, backlog management, and improvement initiatives.

3. Assists in the updates and enhancement of quality system processes for Clinical & Medical Affairs, aligning with business strategies, roadmaps, and Informatics demands.

4. Serves as a primary point of contact between Clinical & Medical Affairs and other departments, driving cross-function cooperation and ensuring stakeholder alignment.

5. Coordinates change requests and submissions, ensuring all critical parties are aligned and changes are effectively implemented.

6. Works with a diverse global team, emphasizing project management, business analysis, service management, solution ownership, and validation to achieve targeted outcomes.

7. Promotes application standardization through shared processes, data harmonization, and architectural compliance, while fostering strong relationships.

8. Leverages expertise in Clinical & Medical Affairs to propose innovative ideas that support the function meeting their objectives.

9. Ensures compliance with training requirements and driving continuous improvement for the clinical programs.

10. 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:

11. You have a minimum of 10+ years’ combined experience in Medical Device Clinical Research and Medical Device development within FDA regulated OEM product environments.

12. You have proven experience in clinical validation, measurement, sustaining, as well as design, execution and oversight of clinical research, planning and associated technologies/tools. Experience in Patient Monitoring (desired).

13. You have a minimum of 3+ years’ experience in Project/Program management and/or Team leadership, with proven experience in budgeting, training, staff development, resource allocation, continuous improvement, etc.

14. You have a detailed understanding of Clinical & Medical Affairs, leveraging expertise to propose innovative ideas, providing meaningful input and contribute to senior leadership discussions.

15. 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.

16. 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.

17. 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.

18. You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this.

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.

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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 .

#LI-EU

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