TekOne IT Services Pvt. Ltd.

Clinical Project Manager

TekOne IT Services Pvt. Ltd. United States
TekOne IT Services Pvt. Ltd.

Clinical Project Manager

TekOne IT Services Pvt. Ltd. United States
1 month ago 31 applicants

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

  • 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.

Education And Experience

  • Degree in the sciences, medicine or similar discipline highly preferred.
  • Minimum of 5+ years of related work experience.

Top Skills

  • 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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