Senior Global Clinical Trial Manager Phase 3

Your responsibilities will be but not limited to:

• Lead the overall initiation, coordination, implementation and management of Phase III international clinical trial
• Lead the cross functional study team dedicated to the clinical study to ensure clinical program goals and timelines are met
• Manage operational and technical aspects of projects including budgeting, timelines and risk management
• Anticipate potential issues and risks within the clinical program, create contingency plans and drive solution implementation
• Select, manage and coordinate external vendors, such as Contract Research Organizations (CROs), central laboratories, etc. You may be involved in the selection process, depending on study status
• Monitor vendor and CROs performance and ensure continuous oversight
• Assist in the identification of investigational sites and coordinate co-monitoring with CRAs when required
• Represent clinical operations on multi-function project teams internally and externally, if needed; report on study progress
• Establish study milestones and ensure accurate tracking and reporting of study metrics and timelines, alert in case of deviations or risks, and propose mitigation plans
• Ensure the delivery of the clinical study according to ICH GCP (E6-R2), local applicable regulations and company’s specific SOPs
• Provide operational input (and scientific if appropriate) into Protocol synopsis, Study protocol and all other study related documents
• Design, review and approve of all trial related documentation, and establish trial processes

Requirements:

• Bachelor or Master’s degree or equivalent in Life Sciences
• Proven track record of 5-7 years of experience as Clinical Trial Manager or comparable operating experience in Pharma (sponsor), including experience leading global Phase III studies from set-up to close-out
• As Clinical Trial Manager, you have worked on various disease areas, including rare disease and oncology
• Experience in Management and Filing of Trial Master File (Veeva Vault knowledge is a plus)
• Customer oriented and strong team-spirit with the ability to lead a cross-functional team and foster a collaborative team environment to work effectively with others in a fast-paced matrix organization
• Capable of anticipating obstacles and bottlenecks and acting as a problem solver with a sense of urgency
• A first experience in external audits is an asset
• Strong negotiation skills, scientific knowledge and involvement
• Former experience in contributing to protocols and clinical development plans
• Fluent in English – French is an asset
• Travel up to 20%