Clinical Trial Manager

A well-established CRO is seeking a Clinical Trial Manager (CTM) to join its Clinical Operations Department. The role of Clinical Trial Manager is a strategic one within the Clinical Operations team; the CTM is responsible for the oversight of the monitoring activities and primarily responsible for site management and relationship building during the conduct of a clinical study support to the Clinical Division.

Job Responsibilties:

• Assisting in the assessment of potential CRO/third-part vendors for capacity and capability to provide study related services
• Working with the clinical team to collect and assess feasibility information for potential sites
• Piloting the budgeting and contracting process to add clinical sites to a clinical study
• Development and management of the study Monitoring Plan; carried out in conjunction with other key functional areas, such as those areas responsible for clinical science, IMP supply (packaging/labelling and distribution), drug safety, data management, etc.
• Managing the monitor training program for a clinical study; including training at the Investigator Meeting as well as on-site, individual monitor training, as needed
• Site management visits conducted regularly to ensure site is prepared for the proper execution of the study and to ensure the site stays engaged with the company in a positive way, to ensure robust study conduct; carried out in compliance with study requirements to optimize data utility and integrity
• Review of site activities and status of inter-related departmental activities, so as to approve and authorize site closure
• Ensure sites are closed appropriately
• Ensure the completeness of the TMF before final archiving in collaboration with the Clinical Trial Assistant and the Lead CTM
• Other tasks, as delegated by the Lead CTM/Head of Clinical Operations

Skills and Requirements:

• A minimum of a bachelor's degree in a scientific or health-related field is required; or equivalent experience.
• Minimum five years of experience in the biotech, pharmaceutical, contract research organization arenas; working as a clinical operations manager. Or 5+ years as a monitor, ideally with clinical lead experience
• Demonstrated proficiency in all aspects of clinical monitoring and oversight of contract resources
• Fundamental working knowledge of ICH, FDA and EMEA GCPs
• Excellent organizational, written and oral communication skills in English are required, with multiple languages preferred, including French
• Self-Motivated
• Demonstrate proficiency at working alone or within a team setting
• Flexibility and the ability to respond to study challenges
• Travel requirements 15-25%
• Swiss resident or EU national

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 Valaince Penteng on +44 203 8460 643 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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