Senior Clinical Project Manager

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