Job Overview
- Assesses feasibility of research protocols based on knowledge and experience and in accordance with designated criteria to select the most suitable studies for the clinical site.
- Supervises the conduct of clinical trials in accordance with ICH GCP, applicable regulations, procedures, and protocols, by monitoring the safety of patients, completeness of research documentation and proper study conduct.
- Monitors individual stages of budget negotiations and research timelines.
- Manages the team of Lead Coordinators, oversees the quality and results of their work by monitoring and follow-up of study related reports, timesheets, site trackers and any other available tools to ensure satisfactory performance of the MO1 team.
- Ensures continuous improvement and standardization of the research process, its continuity and consistency with ICH GCP, regulations, procedures and research protocols by co-creating operational procedures, templates, guidelines related to the work of medical staff and the site in clinical studies.
- Creates a work culture environment that promotes process transparency, high performance and openness.
- Manages and supervises the teams’ work, ensuring the development of individual team members through regular, open feedback, periodic support meetings, providing training and guidance. Provides performance evaluation in accordance with the employee evaluation system to maintain motivation and commitment at work.
- Supervises and participates, when necessary, in audits and inspections, supports the Milestone One team and the medical team at the site by ensuring a reliable and smooth audit process.
- Build and sustain long-lasting relationships with existing and potential clients (sponsors, CROs, medical institutions).
- Support network development activities by active promotion of Milestone One brand by acquiring new clinics and new medical institutions to the network.
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