Clinical Validation Specialist

2 settimane fa

Bologna, Italia BAXTER A tempo pieno

**This is where you save and sustain lives**

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

JOB SUMMARY:
Working with the engineers and using the documentation, the person will be responsible for helping in study documentation definition and execution according to plans and deadlines. Executes verification and validation activities per schedule in cooperation with the V&V team reporting all observed issues. Assist with investigations and with the organization of outside testing.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

- Researches and helps establishing clinical and/or usability study objectives, scope and schedule in support of assigned new product development and sustaining engineering projects.
- Creates and reviews protocols for completeness and feasibility.
- Helps clinical research activity on assigned product(s), including selection, communication of all study participants.
- Responsible for correct and exhaustive documentation of clinical study activities.
- Travels up to 30%, including internationally when needed.
- Carefully documents the results of all the performed activities; reports missing documentation and helps completion.
- Investigates issues if required
- Based on projects scheduling, runs verification and validation tests with the V&V team reporting all issues discovered during the execution.
- Helps documenting the results of the verification or validation process; delivering the documentation in good order and ready to be processed.
- Assist in the organization of outside testing, review reports and provide administrative support.
- Perform and document preliminary user tests.

EDUCATION, EXPERIENCE AND QUALIFICATIONS:
Essential competencies:
Office Word and Excel knowledge needed.
Computer usage and managing
fluent in English
Education, Certifications and prior work experience
include at least an Associate Nursing Degree and/or 3-5 years relevant experience.

Technical skills and abilities:
Basic Excel skills, basic Word skills, basic computer management skills; troubleshooting capability.

Behavior skills and competencies:
easily learn new skills and concepts,
ability to work well in team,
calm under pressure,
open to new ideas
detail oriented

Valued but not required competencies:
Education, Certifications and prior work experience
EKG, Stress test and Holter scanning equipment knowledge acquired in a clinical environment.

Skills and Abilities
Strong capability for trouble shooting,
being systematic and precise,
being determined to have problems solved.

**Reasonable Accommodations**

**Recruitment Fraud Notice**

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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