Senior Clinical Project Manager Oncology

Senior Clinical Project Manager Oncology

My client is an innovating, dynamic and niche international biopharma company currently expanding their clinical development team.

Due to this growth my client is looking for a Senior International Clinical Project Manager with strong Oncology experience on phase III to join them in Lausanne area.

 

Your responsibilities :

 

       Lead the overall initiation, coordination, implementation and management of large international Phase III clinical trials from start-up to close out.

       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, study initiation and risk management;

       Anticipate potential issues and risks within the clinical program, create contingency plans and drive solution implementation;

       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; 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;

       Provide operational input (and scientific if appropriate) into Protocol synopsis, Study protocol and all other study related documents;

       Select, manage and coordinate external vendors, such as Contract Research Organizations (CROs), central laboratories, etc;

       Monitor vendor and CROs performance and ensure continuous oversight;

       Design, review and approve of all trial related documentation, and establish trial processes.

 

Your profile :

 

       University degree or equivalent in Life Sciences.

       Fluent in English – French is an asset

       Must have experience working in Oncology studies

       Proven track record of successful management of large complex Phase III international clinical trials in the Pharmaceutical Industry or CRO.

       Deep knowledge and experience on the implementation and use of EDC, IWRS, eTMF, CTMS and any other digital clinical trial systems.

       Experience in management of CROs, vendors and consultants.

       Strong project management skills.

       Excellent budgeting, planning, and communication skills.

       Ability to lead and influence a cross-functional study team and external partners.

      Willingness to travel up to 30%

axmanag info@axepta.com