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Senior Clinical Project Manager

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Date: Jan 14, 2023

Location: Budapest, HU

Company: Richter Gedeon Nyrt.

Your responsibilities

  • Conceptional planning and implementation of clinical development strategies
    • Development and review of clinical strategies and relevant documents e.g., briefing documents for authority interactions
  • Participation in scientific advice meeting, e.g., contribution to the development of relevant briefing documents and presentations
  • Responsible for all clinical operational aspects pertaining to planning, start-up and management of clinical Phase I and III trial, such as:
    • Development and review of e.g., study protocol, informed consent, operational study plans, case report forms and documents for regulatory submissions
    • Identification, selection and management of external service provider and CROs
    • Organizing and facilitating study team meetings and telephone conferences with external service partners
    • Overseeing and regular reporting of study progress to ensure completion within agreed timelines/milestones and budget
    • Perform sponsor visits at study sites
    • Interactions with Regulatory Affairs, Drug Supply, Drug Safety and other relevant company functions or external development partners
    • Develop and control agreed study budget in liaison with finance department
  • Development of Standard Operating Procedures (SOPs)
  • Plans and actively contributes to GCP audits and inspections
  • Responsible for filing and maintenance of study/project documents

Your background

  • University degree in the field of Medicine/Pharmacy/Science
  • 5 years in international clinical project management
  • proficiency in English

We offer

  • Extensive package:
    • cafeteria, stock program, private life insurance, R&D allowance
  • Company car (including private usage), plus fuel card for private use
  • Hybrid working environment: 2 days Home Office per week
  • Training and development opportunities
  • Private medical services (Medicover) 
  • Various sport and health opportunities (gym, swimming pool, sauna, AYCM)
  • Professional team in a state-of-the-art working environment 
  • Long-term employment in an innovative and secure workplace