Clinical Programs Manager - Endovascular Aortic Repair

Requisition ID 2022-11998
Posting Date 2 months ago(12/9/2022 10:17 AM)
Job Location(s)
Bloomington IN United States
Travel
More than 75%
Position Type
Full Time
Company
Cook Medical LLC
Category
Clinical

Overview

  • Assist in developing the Clinical Programs vision and business strategy for assigned specialty(s) and/or geographic area, in alignment with Division mission, vision and purpose, Division program priorities, and overall company priorities.
  • Execute the Clinical Programs strategy for assigned Division specialty(s).
  • Ensure Clinical Programs are efficient, effective, and compliant in meeting the needs of external and internal stakeholders and communicate those needs to Division leadership.

Responsibilities

  • Assist in forming a structure for Clinical Programs to allow for global direction and alignment across programs, while accommodating for local and regional regulations and needs.
  • 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, in collaboration with clinical affairs.
  • Work with product management, engineering, and other division stakeholders to provide clinical input into the product development process.
  • Develop and lead initiatives to educate healthcare professionals about division product offerings through scientific publications, presentations, in-services, and 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 with relevant products/procedures in the medical device industry.

 

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.

Physical Requirements/Work Environment:

  • Ability to travel domestic and weekends as needed up to 75% (more than 75% travel is possible if home- office based).
  • Work under general office environmental conditions.
  • Subject to applicable federal, state or local law, proof of authorized COVID19 vaccination is required for this position.

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