Mantell Associates is partnered with a growing Biotech organisation in their search for a Clinical Trial Manager to join their team.
Clinical Trial Manager - Responsibilities:
Manage 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
Accountable for the Vendor selection/management, budgeting, timelines, quality, and risk planning for global studies
Communicate 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
Coordinate start-up activities and ensure that essential document quality meets the expectation of Regulatory Compliance Review
Ensure timely regulatory submissions (if appropriate) are addressed
Review and follow up on all questions raised by ethics committees
Clinical Trial Manager - Requirements:
Bachelor's degree or equivalent within a scientific field
Demonstrated Clinical Research Experience
Vendor management, including CRO management
Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +44 (0)20 3854 7700.