44 days ago on ctcon.ch

Study Start-Up Specialist/Contract Manager -Switzerland

CTC Clinical Trial Consulting AG

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Study Start-Up Specialist/Contract Manager -Switzerland

Reference Number: 895094-W
Type of placement: Contract, 12 months (high chances of extension)
Location: Switzerland, North West


The scope of this position lies in Managing Study Start-up activities, Feasibility, and Contract Submission/ Approval activities for Clinical Studies in Switzerland and contract management/ negotiation activities for the studies

Main Responsibilities:

  • Functions as a subject matter expert on all SSU-related activities in the country/region, oversees and leads SSU activities in collaboration with other clinical research stakeholders and serves as a leader for local/global SSU process improvements and patient recruitment strategies.
  • Study start-up coordination and execution.
  • Overseeing the delivery of the contractual obligations and ensuring service providers meet the deliverables in terms of cost, quality and timelines
  • Closely monitors budget spend, ensuring commercial issues are promptly managed and communicated
  • Receive contract request from Hospitals and manage demands from the study sites.
  • New site identification and recruitment, Setting up contract for investigator site.
  • Implementation and execution of international clinical trials phase I - IV in Switzerland.
  • Local Study submission and approvals.
  • Responsibility for the feasibility and the start-up of the studies, as well as during implementation for various operational aspects, including part management of CRO Partners (monitoring), in cooperation with the regional and global study team.
  • Study relevant contacts with investigators, study nurses, ethics committees, Swiss medic, the global study team and div. Internal local Medical Affairs areas have.


Qualifications and Experience:

  • University Degree or Equivalent preferably in a medical/science-related field.
  • Prior work experience demonstrating knowledge and understanding of clinical trials, such as that obtained in a clinical trial monitor capacity, and experience managing projects.
  • Minimum 4 years experience in clinical studies in Switzerland , especially in start up activities and contract management.
  • Demonstrated knowledge and understanding of ICH-GCP, the regulatory, ethics and contractual requirements for starting clinical trials in relevant country.
  • Several years of experience in study start-up activities
  • Communicative, open, accurate and reliable
  • Excellent command of German, English mandatory & conversational French skills could be preferred.
  • Very good MS Office skills, you meet the essential requirements for this job
  • Strong organization skills
  • Customer service orientated
  • Team Player
  • Open to new ideas and to question conventional thinking.
  • Priorities workload and communicate proactively
  • Open-minded and flexibility
  • Relevant working/residency permit or Swiss/EU-Citizenship required