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Clinical Project Lead I

Ft Worth, TX 76134

Posted: 11/28/2023 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 593188 Is job remote?: Yes Country: United States

Job Description

Pay is commiserate with experience and ranges between $80-100/hr
Job description:
  • Act as the primary point of contact for the Clinical project lead and support in Life Cycle Management/Post Production Life Cycle Management activities.
  • Provide clinical functional review and expertise on the assigned projects/tasks.
  • Be responsible for timely authoring (as applicable), revisions, updates on clinical related documents for Medical Device Regulation (MDR) remediation and Post production Risk Reviews (PPRRs).
  • Review large documents such as literature reports, clinical research protocols, and review template documents as assigned by the project lead.
  • Assist in literature review activities as assigned by the project lead and/or CDMA Franchise Head.
  • Attend Clinical team meetings, and any other project meetings as assigned by the Project Lead and represent the function.
  • Complete training activities to better understand product therapeutic area as assigned by the project lead.

Essential requirements:
  • Master's or PhD in vision science, OD, or foreign trained Ophthalmologist; glaucoma experience a plus.
  • Proficient in European Medical device regulations
  • Experience in writing and reviewing medical and clinical evaluation documents
  • Experience in eye care/ophthalmology is preferred
  • Strong communication and writing skills
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