The Country Study Manager is a critical position within Medical team. The successful candidate provides leadership and strategic planning and operational delivery of assigned clinical studies through all phases of study management (preparation, study start-up, conduct, close-out), in accordance with Roche quality standards, all applicable regulations, timelines and budget commitments. Highlight of the main responsibilities are as per below:
• Has full accountability and oversight for all assigned studies at regional/country level (Global and local studies) in accordance with the overall project plan, manages and maintains accurate country/study level plans (e.g. timelines, budget, resource, risk and quality plans) in the appropriate Roche planning system.
• Highlights deviations and risks in plans to relevant parties, develops and implements mitigation strategies as required.
• Plans and executes country study goals and commitments, and ensures compliance to relevant processes.
• Coaches and provides support to responsible study team members.
• Provides study oversight, leadership and support to Contract Research Organization staff to ensure overall delivery at the country and site level, and interfaces with CRO Management regarding feedback on CRO staff performance as required.
• Participates in overall Therapeutic Area support together with the therapeutic leads and country experts (e.g. landscaping activities, investigator/site development activities or affiliate cross functional teams, etc), as required
• University degree or equivalent; preferably in a medical/science
• Related field and extensive experience and expertise in clinical research/development or related industry
• Extensive experience in clinical trial project management
• Strong team player
• Fluency in English
• Ability to travel