Providing Flexible Resourcing Solutions
CTC Clinical Trial Consulting, founded in Basel, Switzerland in 1997, is a specialist staffing organisation, providing flexible resourcing solutions to the pharmaceutical industry in Switzerland, with contract and permanent placements in clinical development, data management, statistics, regulatory affairs and medical marketing.
For one of our clients, we are currently looking for a
Clinical Trial Manager
- Reference Number: 04-09-110-CTM-CRf
- Type of placement: Contract (12 months)
- Location: Switzerland, Basel area
Purpose:
Drive the successful execution of a protocol in a country and/or region from study start up to archiving of the regulatory documents. Interact with the regional operations team to ensure timelines, deliverables, and data quality are met within budget. Handle multiple competing priorities and utilise resources effectively. Provide mentoring guidance, coaching, and feedback to the regional team.
Main responsibilities:
- Lead regional operation trial by ensuring the team is adhering to local regulations and SOPs
- Define and ensure local timelines, deliverables, and data quality are met within budget at the regional protocol level
- Lead monitoring and regional operations meetings for the protocol
- Provide protocol specific training and guidance to regional internal operation team
- Develop, review, and/or provide input into study documents (e.g., monitoring guidelines, CRF instructions, and study budget template)
- Accountable for facilitating, tracking, and monitoring the progress of assigned site activities
- Plan, set-up, and manage the regional trial communication plan, including investigator, monitor, and operational team meeting schedules, overall drug supply, and management and provision of other study materials in accordance with project and study levels plans
- Manage/execute regional operations activities including, but not limiting to country/site feasibility, investigator meeting planning, study and site start up, site management, database lock activities, site closure and TMF archiving
- Manage the regional regulatory document approval process
- Liaise with Regional Operation Managers (ROMs) / Regional Managers (RMs) to ensure that local health authorities, EC/IRB submissions are completed in a timely fashion
- Ensure language translations are completed
- Ensure timely finalisation of contracts (could include budget negotiation)
- Manage investigator payments and invoices
Qualifications and experience:
- University degree in either a biological science or healthcare profession
- Minimum of 4 years of clinical research experience
- Management of local / less complex studies (e.g. Phase II, small Phase III/IIIb studies, open label studies)
- Monitoring experience required
- Understanding of the drug development process
- Understanding of ICH guidelines and GCP
- Advanced computer skills
- Effective oral and written communication skills
- Fluent in English (additional languages advantageous)
- Relevant working/residency permit or Swiss/EU-Citizenship
Our offer:
- Competitive salary and package
- Wide range of career opportunities in a pharmaceutical organisation
- Senior management support and guidance on career planning
- International experience
- Internal training
- Social and professional networking activities
- For applicants from abroad we provide relocation support in terms of obtaining work permits, finding accommodation, tax and legal advice and general information on living in Switzerland
Should you be interested in the above position and wish to apply, please send your application with your CV, quoting the above reference number, to our recruitment team at
recruitment@ctcon.ch
CTC Clinical Trial Consulting, Greifengasse 1, CH 4058 Basel, Switzerland
Tel.:
+41 61 695 88 66 Fax: +41 61 695 88 67
www.ctcon.ch info@ctcon.ch
