The global CRO where clinical trials run on time.
Clinical Operations Manager
Location
Romania
Posted
93 days ago
Salary
0
Seniority
Senior
Job Description
Clinical Operations Manager
PSI CRO AG
• 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.
Job Requirements
- University degree in life sciences
- Minimum 5 years of a clinical on the job experience, in a leadership position at a CRO or SMO
- Fluent use of local language, at least C1 level of English
- Proficiency in MS Office
- Valid driver’s license
- Excellent communications and presentation skills
- Excellent Management Skills
- Effective problem solving and result oriented
- Accountable Team Leadership Skills
- Induction training in SOPs and administration practices for SEO Managers.
- On the job training under supervision of Project Manager Global or designated person
- Sales skills and client engagement experience are considered a strong plus
Benefits
- Accelerate your career with Milestone One!
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