Title : CER Writer / Clinical Project Lead V
Work Location : 100% Remote
Client Location : Fort Worth, TX
Duration : 12 Months Contract
Pay Rate : $75.00 - $85.00 / hr on w2
Job Description :
Key accountabilities :
The contractor will be responsible / accountable for the following,
- Act as the primary point of contact for the Clinical project lead and provide support in Life Cycle Management / Post Production risk review activities
- Activities include but not limited to, understanding and evaluating available clinical data on surgical products, reviewing data against MDR and MDCG Guidance documents and conducting gap assessments and remediation activities
- Provide clinical functional review and expertise on the assigned projects / tasks
- Be responsible for timely authoring (as applicable), revisions, update, on clinical related documents for Medical Device Regulation (MDR) remediation and Post production Risk Reviews (PPRRs), and post-market clinical plans
- Develop template for post-market clinical plan activities, including physician surveys, retrospective / prospective studies etc.
- 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
- 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
- Complete training activities to better understand product therapeutic area as assigned by the manager.
Skills :
Strong experience in clinical evaluations of medical devices (ophthalmology preferred) for life cycle management, and remediation for MDR Good knowledge of the European medical device regulations (MDR), MDCG and PClientF requirements for medical devices
Prior experience in planning / conducting / reporting physician surveys, registries etc is a bonus.
Experience in eye care / ophthalmology is preferred
Strong communication and writing skills Strong project management and meeting facilitation skills.
Education :
Bachelor’s or Masters in Health related fields Excellent understanding of clinical trial regulations, GCP, MDR, MDCG etc.
Comments for Suppliers : Candidate can be remote, the manager is open to local candidates as well
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