What are the responsibilities and job description for the Clinical Programs Manager- Endovascular Aortic Devices position at Cook Group?
Overview
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.