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