CTC Resourcing Solutions, founded in Basel, Switzerland in 1997, is a pan-European specialist staffing organisation with offices in Basel and Cologne, providing flexible resourcing solutions to the pharmaceutical industry across Europe, with contract and permanent placements in clinical development, data management, statistics, regulatory affairs and medical marketing.
Our client is a pioneer in Drug Discovery and Development. As a leading Pharmaceutical company, they work in a vast number of drug & therapeutic areas and are highly recognized internationally. The Swiss affiliate of the global pharmaceutical company is currently looking for a
Study Start-Up Specialist/Contract Manager -Switzerland
Reference Number: 895094-W
Type of placement: Contract, 12 months (high chances of extension)
Location: Switzerland, Basel
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
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