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.
Local Clinical Trial Manager - Responsibilities
Manages all clinical operational and quality aspects of local allocated studies, of moderate to high complexity, in compliance with ICH GCP.
Overall Project Management of study activities and Study plans.
Communicates with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.
Responsible for study recruitment and contingency planning.
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.
Local Clinical Trial Manager - Requirements
Bachelor's degree or equivalent within a scientific field.
Minimum of 2 years Clinical Research Experience.
Oncology experience is desirable.
Fluent in English AND Local Language.