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My client is an innovating, dynamic and niche growing international pharmaceutical company currently expanding their clinical trial team based in Lausanne area.
Due to this growth my client is looking for a Global Clinical Operations Program Head to manage all clinical activities for several programs at a global level (including US, Europe or Asia) and to lead a team of Clinical Trial Managers and Leads.
Global Clinical Operations Program Head
Lead and manage a team of Clinical Trial Leads, ensuring smooth completion of studies as per plans, plan resources, recruit talent, establish meaningful development plans, address performance issues and ensure proper issue resolution as appropriate;
Lead and manage multiple clinical programs through the direct supervision of Clinical Operations Leads / CTLs, and in close collaboration with R&D cross-functional teams, ensuring smooth execution of studies (including budget and contracts review);
Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, for all activities assigned.
Establish solid external providers CROs/Vendors selection and oversight, as well as preferred supplier strategy;
Improve Clinical Operations processes when needed, identify issues and propose solutions and action plans to be implemented by his/her team or by the extended Clinical Operations team, when appropriate, support functional initiatives and processes managed by Clinical Operations Department;
Provide direction for the development of operational plans including enrollment models and risk management plans, financial planning and management, communication plans, and monitoring plans in collaboration with CRO, be accountable for inspection readiness;
Be accountable for the review and expert clinical operations input into clinical documents related to the drug development process;
Attend and represent Clinical Operations department in some of the Management Meetings;
Design, review and approve of all trial related documentation, and establish trial processes;
PhD/University degree or equivalent in Life Sciences with at least 6 years' experience on Phase I-III international clinical trials management in Oncology.
Demonstrated excellence in leadership and project/program management;
Deep knowledge and experience on the implementation and use of EDC, IWRS, eTMF, CTMS and any other digital clinical trial systems;
Solid experience in management of CROs, vendors and consultants, experience in external audits, an asset;
Strong project management skills, excellent budgeting, planning, and communication skills;
Fluent in English (French and another European language are an asset);
Ability to travel according to business needs (10-20%).
My client is an innovating, dynamic and niche growing international pharmaceutical company currently expanding their clinical trial team based in Lausanne area. Due to this growth my client is looking for a Senior Global Clinical Trial Lead Early phases with strong experience at a global level (including US, Europe or Asia) Your responsibilities : - Lead the overall initiation, coordination, implementation and management of international clinical trials at different stages. - 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. - Design, review and approve of all trial related documentation, and establish trial processes - Anticipate potential issues and risks within the clinical program, create contingency plans and drive solution implementation - Manage and coordinate external vendors, such as Contract Research Organizations (CROs), central laboratories, etc. - 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. Your profile : - Bachelor or Master degree or equivalent in Life Sciences - Minimum of 5-8 years of experience as Global Clinical Trial Manager within pharmaceutical industry - Experience leading global Phase I & II studies from set-up to close-out. - As Global Clinical Trial Manager, you have worked on various disease areas, including rare disease and oncology (a must) - Strong negotiation skills, scientific knowledge and involvement - Fluent in English
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