Cook Medical

Clinical Programs Manager- Endovascular Aortic Devices

Cook Medical  •  Bloomington, IN (Onsite)  •  6 days ago
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Job Description

Remote-based in the US, preferably near a major hub airport

Will be responsible for clinical programs supporting Endovascular Aortic Repair product lines. Extensive Endovascular Aortic repair product and procedural knowledge is required.Prior project management experience or capability required

Assist in developing the Clinical Programs vision and business strategy for product(s) and/or geographic area.

Execute the Clinical Programs strategy for assigned product line(s).

Ensure Clinical Programs are efficient, effective, and compliant in meeting the needs of our customers and internal stakeholders, and communicate those needs to Division leadership.

Responsibilities

Essential Job Functions/Duties:

Assist in developing, communicating, leading, and implementing the Division’s strategies for clinical studies, site selection, enrollment, customer/site support, and collaboration with external Subject Matter Experts (SMEs) to complete trials and build awareness for Vascular programs.

Work with product management to determine clinical data requirement for both regulatory and business purposes. Work closely with Division and functional stakeholders to design and implement clinical studies.

Support the Division and functional stakeholders with selection, agreement process, and maintenance of Physician Sponsored Investigational Device Exemption sites.

Initiate and build relationships with external SME’s to support Clinical Studies.

Work with product management and engineering to provide clinical input into the product development process.

Develop and lead initiatives to educate customers about division product offerings through scientific publications, presentation and in-services, as well as other appropriate educational forums

Work closely with the Medical Education Function to provide clinical and scientific support.

Meet deadlines and complete administrative tasks such as expenses, training, reporting, policy acknowledgements, etc. in a timely manner.

Maintain our culture, values, and commitment to Ethics and Compliance through recognizing, demonstrating, and enforcing appropriate and compliant behavior.

Within scope of responsibility, ensure all quality, regulatory, and product specific requirements are met.

Understand and be accountable for conducting Cook business with integrity and in compliance with applicable standards including Cook policies.

Qualifications

Required Experience:

College degree in related field and/or equivalent relevant experience.

Extensive clinical/product experience in Endovascular Aortic repair in the medical device industry.

Prior project management experience and/or demostrated capability

Preferred Qualifications:

Demonstrate excellent communication, leadership, and presentations skills.

Model the company standards that others are expected to follow.

Demonstrate positive and constructive behaviors that drive team cooperation in achieving objectives.

Demonstrate the ability to think strategically.

Actively involved in mentoring peers within current department.

Active participant/presenter/leader in meetings, conference calls, and/or training activities.

Qualified candidates applying to be based in the United States must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Cook Medical

About Cook Medical

At Cook, we are building our future on Invention, Connection, People, and Community.

As a privately owned company, we can look at the world our own way and do what we feel passionate about. What are we passionate about? That’s simple: Making unique, quality products and connecting with people to improve lives on both sides of the device.

Central to our focus on building deep connections is our belief in the importance of identifying innovative solutions to help customers, patients, employees, and communities thrive. We understand that our ongoing success will come from creating inclusive, supportive, and healthy environments where we can prosper together. Our people are our greatest asset and are at the heart of everything we do. Come build with us.

Industry
Manufacturing & Production
Company Size
5,001-10,000 employees
Headquarters
Bloomington, Indiana
Year Founded
1963
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