Study Start-Up Specialist
The scope of this position lies in Managing Study Start-up activities, Feasibility, and Contract Submission/ Approval activities for Clinical Studies in Switzerland.
- 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
- 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