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The Manager is accountable for ensuring accurate planning, prioritization across teams and timely execution working closely with site engagement at the affiliates and across the trial capabilities teams. The scope of the work includes activities related to investigator sites readiness; maintenance and close out ensuring country specific requirements are met. The manager is responsible for ensuring inspection readiness through a complete, accurate and readily available Trial Master File.
The Manager provides leadership, direction and technical support to the Clinical Trial Capabilities assistants focusing on results and driving efficiency to achieve goals and objectives.
- Accountable for meeting and exceeding goals for clinical trial operations for development programs
- Manage communications/relationships and serve as the point of contact for the trial capabilities team deliverables during the site initiation, maintenance and close out representing progress to business partners.
- Provides expertise in conducting clinical research and keeping up to date with Country/Regional regulatory requirements.
- Develop streamline processes ensuring efficiency and improved productivity as well as meeting customer requirements.
- Recruit, develop and retain a scientific and operationally capable workforce skilled and knowledgeable in clinical development
Basic Qualifications required:
- Bachelor’s degree preferably in a scientific or health related field, two years clinical research experience or relevant experience preferred
- Understanding of the overall clinical development paradigm and the importance of efficient site initiation
- Previous supervisory experience