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 :
Ø Lead the overall initiation, coordination, implementation and management of large international Phase III clinical trials from start-up to close out.
Ø Lead the cross functional study team dedicated to the clinical study to ensure clinical program goals and timelines are met;
Ø Manage operational and technical aspects of projects including budgeting, study initiation and risk management;
Ø Anticipate potential issues and risks within the clinical program, create contingency plans and drive solution implementation;
Ø Assist in the identification of investigational sites and coordinate co-monitoring with CRAs when required;
Ø Represent clinical operations on multi-function project teams internally and externally; report on study progress;
Ø 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;
Ø Provide operational input (and scientific if appropriate) into Protocol synopsis, Study protocol and all other study related documents;
Ø Select, manage and coordinate external vendors, such as Contract Research Organizations (CROs), central laboratories, etc;
Ø Monitor vendor and CROs performance and ensure continuous oversight;
Ø Design, review and approve of all trial related documentation, and establish trial processes.
Your profile :
Ø University degree or equivalent in Life Sciences.
Ø Fluent in English – French is an asset
Ø Must have experience working in Oncology studies
Ø Proven track record of successful management of large complex Phase III international clinical trials in the Pharmaceutical Industry or CRO.
Ø Deep knowledge and experience on the implementation and use of EDC, IWRS, eTMF, CTMS and any other digital clinical trial systems.
Ø Experience in management of CROs, vendors and consultants.
Ø Strong project management skills.
Ø Excellent budgeting, planning, and communication skills.
Ø Ability to lead and influence a cross-functional study team and external partners.
Ø Willingness to travel up to 30%