Remote Clinical Project Lead V
Fort Worth Metro Area, TX 76134 US
R&D Partners is seeking to hire a Remote Clinical Project Lead V
Your main responsibilities as a Clinical Project Lead V
- 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
What we are looking for in a Clinical Project Lead V:
- Bachelor's Degree with Clinical Operations/Development experience from a sponsor or CRO company
- Excellent understanding of clinical trial regulations, GCP, MDR, MDCG etc.
- 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
- Strong communication and writing skills
- Strong project management and meeting facilitation skills
Pay Scale $68.56-$85.70 (Dependent on Experience)
R&D Partners is a specialist employment agency and recruitment business providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
R&D Partners is an equal opportunity employer.