In this role you will be responsible for leading, planning, managing and delivering large international Phase III clinical trials in Oncology. You will ensure that studies are carried out according to the protocol, SOPs, principles of Good Clinical Practice and other applicable regulations.
- Lead initiation, coordination, management and implementation of large international Phase III clinical trials (start-up to close out)
- Manage the cross functional study team assigned to the clinical study and ensure that clinical program goals and timelines are met
- Manage operational and technical aspects of projects such as budgeting, study initiation, risk management, etc.
- Foresee potential issues and risks within the clinical program, create contingency plans and drive solution implementation
- Select, manage and coordinate external vendors, suppliers, Contract Research Organizations (CROs), central laboratories, etc.
- Monitor suppliers and CROs performance and ensure continuous oversight
- Support the identification of investigational sites and coordinate co-monitoring with CRAs (when required)
- Continuously report on study progress and act as a representative of clinical operations on multi-function project teams internally and externally
- Establish study milestones and provide accurate tracking and reporting of study metrics and timelines, report any deviations or risks, and develop mitigation plans
- Ensure the delivery of the clinical study according to ICH GCP (E6-R2), local applicable regulations and client’s specific SOPs
- Provide operational input (and scientific when appropriate) into Protocol synopsis, Study protocol and any other study related documents
- Design, review and approve of all trial related documentation
- Establish trial processes
- Master or PhD degree in Life Sciences.
- Fluent in English, French is a plus
- Mandatory experience in managing large scale clinical trials
- Oncology experience in preferred
- Proven track record of successful management of large complex Phase III international clinical trials in the Pharmaceutical Industry or CRO
- Previous monitoring experience is a plus
- Strong knowledge and experience in the implementation and use of EDC, IWRS, eTMF, CTMS and other digital clinical trial systems.
- Experience in management of suppliers, CROs, vendors and consultants.
- Experience in external audits is a strong asset
- Excellent project management skills (budgeting, planning, communication)
- Mandatory experience in contributing to protocols and clinical development plans
- Willingness to travel (10-30%)