Junior Clinical Project Manager

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Date: Sep 8, 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
  • Guidance and support in 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
  • Overseeing and regular reporting of study progress to ensure completion within agreed timelines/milestones and budget
  • 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 Profile

  • At least 1 year experience in international clinical project management
  • Solid knowledge of Good Clinical Practice (GCP) comprehensive understanding of Clinical Development
  • Strong background in strategic and conceptual planning of – ideally but not exclusively – biosimilars
  • Ability to cover the complete development chain, including discussions with Health Authorities
  • A mature, seasoned individual who can infuse the Richter organization with best practices and take an active part in the ongoing culture change of the company
  • A hands-on attitude and a flexible mindset; ability to find quick solutions to problems; agile, resourceful
  • Proficiency in English
  • University degree in the field of Medicine/Pharmacy/Science

We offer

  • Extensive benefits package: competitive base salary, cafeteria, stock program, private life insurance
  • Training and development opportunities
  • Medical services (Medicover) 
  • Various sport and health opportunities (gym, swimming pool, AYCM)
  • Challenging, responsible professional work in a state-of-the-art environment
  • Long-term employment in an innovative and secure workplace