- Represent Clinical Development Operations at Project level for a specific compound, and handle preliminary activities as required, providing operational input to the project planning.
- Handle cross functional project assignments and / or cross-functional leadership activities.
- Lead a cross-functional team with focus on operational activities.
- Lead the implementation of the operational strategy to ensure all operational trial deliverables are provided on time and within the agreed cost.
- Oversee the resource forecast for cross-functional and regional teams.
- Accountable for ensuring an adequate site selection, in collaboration with other functions.
- Develop high level country plans and site strategy plans in collaboration with program and trial teams.
- Accountable for the oversight of operational committees and vendors, including availability of key documents and adherence to key timelines.
Qualification :
- Bachelor of Science degree or equivalent University degree in life sciences or healthcare.
- At least 10 years of experience in managing operational aspects of complex Phase II and Phase III clinical trials and global teams.
- Experience in leading global cross-functional (matrix) and multicultural teams.
- Experience in having direct reports and leading teams.
- Previous involvement in high complexity trials, with ability to overcome challenges and impact study conduct.
- Intensive experience in selecting and managing External Service Providers (ESP), including performance assessments and finance management.
- Experience working with electronic data capture, electronic Trial Master File and Clinical Trial Management Systems
- Excellent knowledge of ICH-GCP.
Global Lead Lead • Basel and NW Switzerland, CH