Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs
Oversee the execution of Site Activation and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines
Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan
Ensure collaboration across Regulatory & Site Activation
Create and/or review technical and administrative documentation
Provide specialist regulatory and technical scientific support
Mentor and coach colleagues as required.
Requirements
Bachelor's Degree in Life sciences or related field
7 years’ relevant experience in a scientific or clinical environment including demonstrable experience in an international role.
Thorough understanding of regulated clinical trial environment and in-depth knowledge of drug development process
Strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines