Inserat vom Sonntag, 17. Februar 2019

Senior Clinical Trial Manager

  • Lausanne
  • Festanstellung, 100%
  • Fach­verantwortung

Senior Clinical Trial Manager

Debiopharm Group? (Debiopharm) is a Swiss - based biopharmaceutical group of four companies active in drug development, GMP manufacturing of proprietary drugs, diagnostics, and investments. Debiopharm International SA searches, evaluates and in - licenses promising drug candidates for development. Towards the end of the development process, the products are licensed out to pharmaceutical companies for world - wide marketing and sales. For our Clinical Ope rations Service, Clinical Research & Development Depar tment based at our Headquater in Lausanne, we are looking for a SENIOR CLINICAL TRIAL MANAGER (1 year contract) The Sr. Clinical Trial Manager (CTM) is reporting to the Director, Clinical Operations and , is responsible and accountable for leading , planning, and deliveri ng clinical trials (Phases I ? III ) in Oncology and onco - h aematology, to ensure that studies are carried out according to the protocol, SOPs, applicable regulations and principles of Good Clinical Practice. Your responsi bilities : · Manage the cross functio nal study team dedicated to the clinical study to ensure clinical program goals and timelines are met ; · Manage operational aspects of projects including budgeting, study initiation and risk ma nagement; · Select and manage external vendors, such as Contract Research Organizations (CROs), central laboratories, etc. ; · Assist in the identification of investigational sites and perform co - monitoring with CRAs when required ; · Represent clinical operations on multi - fun ction project teams internally and externally ; re port 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 GC P (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 d ocumentation, and establish trial pro cesses ; · Give operational input (and scientific if appropriate) into Due Diligence activities. Your profile : · University degree or equivalent in Life Sciences . · Fluent in English, French and another European language are an asset. · Oncology experience highly preferred . · Proven track record of Phase I - III international clinical trials m anagement in the Pharmaceutical Industry or CRO . P revious m onitoring experience preferred. · D eep knowledge and experience on the implement ation and use of EDC, IWRS, eTMF, CTMS and any other digital clinical trial systems. · Experience in management of CROs, vendors and consultants. · Experience in external audits, an asset. · S trong project management skills . · Excellent budgeting , planning, and c ommunication skills. · Capable of anticipating obstacles and bottlenecks and acting as a problem solver with a sense of urgency. · Ability to lead a nd influence a cross - functional study team and external partners . · Strong negotiation skills. · Strong scientific involvement. · Former experience in contributing to protocols and clinical development plans. · High degree of initiative an d ability to work independently. · Willingness to travel according to business nee ds (10 - 30%). Debiopharm International can offer you: · A n international and highly dynamic environment. · The opportunity to join a successful company, at the forefront of the most advanced scientifi c developments in the industry. · The possibility to be in a company in which innovation, people and entrepreneurshi p are the fundamentals of its success. For more information :

CP 5911 /Chemin Messidor 5-7 1002 Lausanne


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