Operations Manager, Clinical Research

🔥 2 minutes ago

🇹🇼 Taiwan – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🏥 Clinical Operations

👻 Ghost score 10%

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PSI CRO AG

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1996

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

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.

📋 Description

• Oversee the operational conduct of clinical trials at contracted medical institutions within a defined country or region • Provide leadership to Lead Site Coordinators and Site Coordinators as a subject matter expert and escalation point for operational issues • Assess feasibility of research protocols by reviewing clinical, operational, and resource requirements and recommending suitable trials • Monitor budget negotiations and study activation timelines to support timely site readiness • Manage Study Coordinators and oversee the quality and results of their work through study reports, timesheets, site trackers, and other operational tools • Drive process improvement and standardization of clinical trial operations in alignment with ICH GCP, regulatory requirements, and controlled documents • Contribute to operational guidelines, templates, and procedures • Create a work culture promoting process transparency, accountability, and continuous learning

🎯 Requirements

• Associate degree in life sciences or similiar • Business Management degree or certification is a plus • ICH GCP Training • Minimum 5 years of clinical on the job experience, in a leadership position at a clinical research facility or Network experience is highly preferred • Knowledgeable and direct experience in the full life cycle of clinical research activities from pre-award through close out • Fluent use of English • Proficiency in MS Office • Valid category B driver’s license • Excellent communications skills • Excellent management skills, experience managing remote staff preferred • Effective problem solving and result oriented • Accountable Team leadership skills

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