Clinical Operations Manager

🔥 47 minutes ago

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PSI CRO AG

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1996

⚕️ Healthcare Insurance

💊 Pharmaceuticals

🔬 Science

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.

📋 Description

• Line manage, coach, mentor, and develop Clinical Research Associates across multiple experience levels. • Manage hiring, onboarding, performance management, and professional development activities. • Oversee resource allocation, workload planning, and utilization across clinical trials. • Collaborate with Project Managers and cross-functional teams to ensure successful study delivery. • Monitor staff performance and support operational efficiency through established departmental metrics. • Implement departmental quality controls and contribute to the development and continuous improvement of quality systems and processes. • Prepare for and participate in internal audits, sponsor audits, and regulatory inspections. • Support trial execution by resolving operational challenges and facilitating communication between project teams and investigational sites. • Participate in feasibility assessments for new and ongoing studies. • Support business development activities, including client meetings, networking events, and operational discussions, as needed.

🎯 Requirements

• MD, PharmD, or a university degree in Life Sciences, or an equivalent combination of education, training, and experience. • Minimum of 5 years of clinical research industry experience, including demonstrated team management or people leadership experience. • Previous experience working independently as an onsite Clinical Research Associate (CRA) is required. • Previous experience managing or mentoring clinical research professionals in a CRO, sponsor, or related clinical research environment. • Strong leadership, coaching, and employee development skills. • Experience with resource planning, workload management, and performance management. • Working knowledge of ICH-GCP, applicable regulatory requirements, and clinical trial operations. • Experience supporting audits, inspections, and quality initiatives is preferred. • Excellent communication, organizational, and problem-solving skills. • Proficiency with Microsoft Office applications and clinical research systems. • Advanced English proficiency (written and spoken). • Strong interpersonal skills with the ability to build trust, foster collaboration, and develop high-performing teams.

🏖️ Benefits

• All your information will be kept confidential according to EEO guidelines