Clinical Project Manager
Clinical Project Manager
TekOne IT Services Pvt. Ltd.
United States
See who TekOne IT Services Pvt. Ltd. has hired for this role
Role: Clinical Project Manager - B
Location: St. Paul, MN - 55117
Duration: 10 Months on W2 (Possible project extension)
Job Description
Location: St. Paul, MN - 55117
Duration: 10 Months on W2 (Possible project extension)
Job Description
- Clinical Project Manager for Post-Market Safety Evaluations
- Project Management with strong Writing experience.
- Work with the Post Market Safety Evaluation Team.
- Managing contract writers. Do review and editing work.
- Work on Periodic Safety Update Reports(PSUR), PMS Plans.
- Experience with Clinical evaluation, writing, CERs; Clinical writing experience in accordance with MDR 2017/745.
- Knowledge of PMS Plans / PSURs / PMS Reports in accordance with the EU Medical Device Regulations (MDR 2017/745)
- Exp working in big corporations.
- Exp with Post marketing is the desired skill set.
- Understanding of regulations, standards, and guidelines related to medical devices, clinical studies, and quality systems, including MDR 2017/745; MDD 93/42/EEC; AIMDD 90/385/EEC; MEDDEV 2.7/1 Rev. 4; ISO 14971; ISO 14155; ISO 13485.
- Degree in the sciences, medicine or similar discipline highly preferred.
- Minimum of 5+ years of related work experience.
- Experience in writing Clinical Evaluation Reports.
- Exp in writing Periodic Safety Update Reports.
- Managing projects.
-
Seniority level
Mid-Senior level -
Employment type
Full-time -
Job function
Project Management and Information Technology -
Industries
Human Resources Services
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