Clinical Operations Manager

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4 days ago

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PSI CRO AG

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Healthcare Insurance • Pharmaceuticals • Science

PSI CRO AG is a global contract research organization (CRO) that specializes in conducting clinical trials. The company focuses on delivering pivotal Phase 2 and 3 clinical trials across various therapeutic areas, including Inflammatory Bowel Diseases, Oncology, Hematology, Infectious Diseases, Multiple Sclerosis, and Rare Diseases. PSI utilizes a proprietary technology platform for clinical trial planning and financial tracking to ensure trials are conducted on time and within budget. The company is recognized for its expertise, quality, compatibility, and reliability, having been awarded the CRO Leadership Awards for multiple consecutive years.

1001 - 5000 employees

Founded 1996

⚕️ Healthcare Insurance

💊 Pharmaceuticals

🔬 Science

📋 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. • 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.

🎯 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 • 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

• Paid time off • Flexible work arrangements • Professional development opportunities