Clinical Project Manager

Our client is seeking a clinical project manager responsible for the implementation and execution of international clinical trials in Lausanne, Switzerland.

Job Responsibilties:

• Manage international clinical trials according to time, cost and quality standards
• Negotiate, implement and maintain contracts with study partners (study vendors, sites)
• Manage activities of study partners, support clinical CRO in managing the sites
• Review and approve submission packages for submission to Ethics Committees/Institutional Review Boards
• Supply proper documentation to the Regulatory department for submission to Regulatory Authorities
• Contribute to the generation of SOPs
• Participate in clinical study design
• Create and maintain operational plans
• Prepare study budgeting and forecasting
• Global budget management of trials
• Ensure the accurate planning and ordering of clinical trial drug supply
• Lead study protocol development
• Write and update clinical trial documents
• Participate to review and approval of the Clinical Trial Report

Skills and Requirements:

• Minimum of 4 years of experience in clinical research (preferably with 2 years coordinating international or leading regional trials)
• Previous monitoring experience and knowledge in international standards (GCP/ICH) as well as in international (FDA/EMA) and local regulations
• Hands on experience in writing clinical study documents
• A scientific degree is required as well as the ability to work in a start-up environment, handling multiple demands and strong planning and organisational skills
• Personal features include: - Advanced understanding of timelines, budget and resource management - Planning, tracking and solving skills for maintaining project timelines - Networking skills - Working both independently and in a cross-functional team setting - Good spoken and written English are required; a 3rd language is asset

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Sasha Brasero on +44 203 078 9556 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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