Job description
Mantell Associates is currently partnered with a Top 10 Global CRO who are one of the fastest growing organisations in the world. They are currently looking to strengthen their Clinical Operations team across Europe through the appointment of Global Clinical Trial Managers working in their Clinical FSP team and outsourced to a Top Pharma. These positions will be reporting directly to the Country Heads depending on the location of the successful candidate.
Global Clinical Trial Manager - Responsibilities:
Manages all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP
Overall Project Management of study activities and Study plans
Accountable for the Vendor selection/management, budgeting, timelines, quality, and risk planning for global studies
Communicates with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues
May coordinate all start-up activities and ensures that essential document quality meets the expectation of Regulatory Compliance Review. Ensures timely regulatory submissions (if appropriate) are addressed. Reviews and follows up on all questions raised by ethics committees. Responsibilities may vary based on project timelines
May be required to manage a team of local CRA’s/CTA’s
Global Clinical Trial Manager - Requirements:
Bachelor's degree or equivalent within a scientific field
Minimum of 5 years Clinical Research Experience
Oncology experience is desirable
Vendor management, including CRO management
Fluent in English AND Local Language