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Clinical Evidence Specialist

3 months ago

Houston, Texas, United States Agiliti Full time

The Clinical Evidence Specialist is a key member of the Clinical Affairs team and drives clinical evidence development, key opinion leader development, continuing education program development and other special projects.

This position develops, documents, and executes pre-market and post-market clinical evidence studies across Agiliti-manufactured product platforms/families.

PRIMARY OBJECTIVES AND RESPONSIBILITIES

Clinical Evidence Specialists are responsible for:

  • Collaborating with customers to develop pre
- and post-market clinical evidence on the clinical use of Agiliti-manufactured product and clinical outcomes, in the forms of posters, publications, and white papers

  • Supports product development teams on issues relating to premarket and postmarket clinical evidence needs and studies
  • Collaborating with the Commercial and Clinical team to identify and develop key opinion leaders that will present on clinical outcomes of product at customer and potential customer engagements
  • Gathering and analyzing clinical data, including web analytics, statistics, and trends
  • Identify and collaborate with partner clinical research/outcomes sites
  • Identify and develop customer references

QUALIFICATIONS

  • Fouryear degree required in medical, nursing, biological, physical, or engineering disciplines.
  • Experience in creating conference posters, white papers, and publications, and jointly with clinical research sites
  • Experience in gathering and interpreting qualitative and quantitative clinical outcomes data
  • Experience in acute care hospital setting required; beds and support surfaces highly preferred
  • Knowledge of regulatory requirements relative to clinical investigations in at least one of the following regions: U.S. FDA regulations, the Medical Devices Directive, and ISO 14155 Clinical Investigations standard
  • Experienced in searching medical literature and databases for clinical and technical information
  • Ability to read, analyze, and interpret clinical literature, regulations, guidance documents, clinical and medical terminology, technical product information and complex documents.
  • Ability to create and maintain strong customer relations
  • Strong project management skills with the ability to work independently
  • Proven experience working with multidisciplinary, crossfunctional teams
  • Exceptional written and oral communication skills, including the ability to effectively communicate with clinical, legal, R&D, quality, marketing, and sales audiences
  • Selfmotivated, selfdirecting, strong attention to detail and excellent time management skills
  • Project management skills
  • High level of flexibility, creativity, dependability, and professionalism
  • Excellent presentation skills are essential
  • Demonstrated computer skills preferably spreadsheets, word processing, internet research and other applicable software programs.
  • Travel up to 75%

DISCLAIMER


This job description in no way states or implies that these are the only duties to be performed by the employee in this position.

It is not intended to give all details or a step-by-step account of the way each procedure or task is performed.

The incumbent is expected to perform other duties necessary for the effective operation of the department and the company.

  • It is the policy of Agiliti to provide equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender identity, sex, sexual orientation, national origin, age, physical or mental disability, genetic information, marital status, status as a veteran, military service, or any other characteristic protected by applicable federal, state, or local civil rights laws. In addition, Agiliti will provide reasonable accommodations for qualified individuals with disabilities. Agiliti strictly prohibits any form of retaliation against individuals who make good faith reports of alleged violations of this policy or who cooperate in Agiliti's investigation of such reports. _
  • Affirmative Action Policy Statements_
  • You may be required to obtain certain vaccinations, or provide proof of current vaccination status, based on customer and/or company requirements. If vaccination is required, Agiliti will provide specific directions and cover the expense at a participating clinic. Please note, this includes the COVID19 vaccination._
  • Agiliti is an equal opportunity employer and provides reasonable accommodations to employees and applicants consistent with state and federal law._
  • It is the policy of Agiliti to provide equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender identity, sex, sexual orientation, national origin, age, physical or mental disability, genetic information, marital status, status as a veteran, military service, or any other characteristic protected by applicable federal, state, or local civil rights laws. In addition, Agiliti will provide reasonable