Clinical Project Lead I
6201 South Freeway Fort Worth, TX 76134 US
Job Description
Target pay rates: 35-42/hr (varies on years of experience)
SUMMARY:
Attend Clinical team meetings, Clinical Sub team and Trial Team Meeting and any other project meetings as assigned by the Project Lead/Line Manager and represent the function Activities include but not limited to, understanding, and putting together project plans, protocol synopsis, leading study plan/conduct/reporting activities (all aspects of the clinical trial)
Lead Clinical Sub team meetings, work with a cross functional team and review study designs and formulate research questions/hypotheses. Act as the primary point of contact for the portfolio Clinical project lead and provide support in Life Cycle Management/Postproduction risk review activities as needed Provide clinical functional review and expertise on the assigned projects/tasks Be responsible for timely authoring (as applicable), revisions, update, on clinical related documents Review large documents such as literature reports, clinical research protocols, and review template documents as assigned by the project lead/line manager Assist in literature review activities as assigned by the project lead and/or CDMA Franchise Head Complete training activities to better understand product therapeutic area as assigned by the manager
Complete training activities as assigned by the Manager
?BACKGROUND:
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
Master's or PHD in vision science or trained Ophthalmologist/Optometrist.
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