Clinical Project Lead V
- Location: Fort Worth, Texas
- Type: Contract
- Job #37910
Exciting Contract opportunity to work for a global leader dedicated to helping people see brilliantly. The largest device company in the world – with complementary businesses in Surgical and Vision Care.
Clinical Project Lead V
– 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 PMCF 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 Bachelors or Masters in Health related fields Excellent understanding of clinical trial regulations, GCP, MDR, MDCG etc.
This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!