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Senior Clinical Project Manager
Apply now »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