PSI CRO OPERATIONS MANAGER (CLINICAL TRIALS)

Company Description At Milestone One, our mission is to bring clinical trials to much wider populations of sites and patients around the world.
For too long, clinical trials have only been available to a handful of patients at a handful of hospitals - a unique opportunity for selected few.
Imagine every patient with no hope of a cure having the option of getting access to clinical research enabled by their physician and hospital.
Founded by a team of seasoned professionals with more than 30-years of global industry experience, we bring together driven and dedicated people around the world, working collectively to help make a positive impact on patient lives.
Milestone One partners with research sites to navigate the complexities of clinical trials seamlessly.
From medical equipment rental services to patient support services, we provide end-to-end support tailored to each site’s unique needs empowering them to focus on what truly matters — delivering innovative therapies to patients.
Outstanding quality is at the heart of Milestone One.
We hire only the best professionals on the market.
experienced, engaged, open for development.
Not only excellent specialists but also reliable and supportive team mates – we care not only about our clients but also about our team! Job Description 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.
Qualifications College or university degree in life sciences and minimum 5 years of experience in a leadership position at a CRO or SMO is vital.
Additional Information Take the next step in your career with this exciting opportunity at Milestone One.