Clinical Operations Manager - CO Strategy & Operations, Experimental Medicine(m/w/x)

Beschreibung

You will drive the success of early clinical trials by managing operational lifecycles and budgets. Your day-to-day involves coordinating with global partners to ensure compliant, timely study delivery.

Anforderungen

• •University degree in natural sciences or comparable qualification
• •Significant professional experience in clinical trial management
• •Profound knowledge of pharmaceutical industry and drug development
• •Long-track experience in clinical operations
• •In-depth knowledge of regulatory context and GCP
• •Ability to drive decision-making and innovation
• •Exceptional project management and communication skills
• •Growth mindset and proactive learning approach
• •Fluency in German and English
• •Willingness to travel for trial activities

Aufgaben

• •Oversee operational aspects of early clinical trials
• •Manage trial budgets from purchase orders to invoices
• •Design and plan efficient trial set-ups
• •Coordinate with CROs and external vendors
• •Organize global study and monitoring procedures
• •Provide professional guidance to the trial team
• •Establish monitoring strategies for POC trials
• •Create and curate COM training programs
• •Prepare regulatory submission and monitoring documents
• •Develop appropriate study submission strategies
• •Monitor timelines and resolve potential conflicts
• •Interface with Quality Vendor Compliance
• •Manage non-compliances and CAPA learnings
• •Conduct on-site audits with global stakeholders

Tools & Technologien

Benefits