Beschreibung

As a Clinical Trial Manager, you will oversee the execution of clinical studies, ensuring compliance with regulations and ethical standards. Your role involves managing trial teams, coordinating with vendors, and maintaining strong relationships with investigational sites to drive successful trial outcomes.

Anforderungen

• •Master’s or higher-level degree in life science
• •At least 2 years of clinical trial management experience
• •Significant exposure in managing Early Phase clinical trials
• •Exceptional knowledge of clinical research regulatory requirements
• •Excellent understanding of project financials and vendor management
• •Effective communication skills and fluent in German and English
• •High ability in abstract complex topics and strategic thinking
• •High organizational and planning skills
• •Excellent leadership and collaboration skills
• •High degree of self-accountability and commitment
• •Very good computer skills including Microsoft Word, Excel, PowerPoint
• •Flexibility for occasional business travel
• •Strong problem solving skills
• •Ability to make decisions and drive results

Aufgaben

• •Manage execution of clinical studies
• •Orchestrate local trial team activities
• •Integrate with other functions during trial phases
• •Work within GCP and regulatory environments
• •Collaborate with multidisciplinary international teams
• •Lead local trial team in preparing trial documents
• •Support investigative sites in contract and approval processes
• •Ensure compliance with ICH-GCP and regulatory regulations
• •Uphold ethical standards and patient safety
• •Plan and conduct trials in line with regulatory requirements
• •Set up and manage trial budgets
• •Review budget updates based on trial changes
• •Act as primary contact for vendors
• •Manage vendor-related activities as per project needs
• •Provide trial-specific training to internal and external partners
• •Develop relationships with investigational sites
• •Support CRAs in site communications
• •Monitor compliance of trial sites with GCP and regulations
• •Ensure adequate trial supply distribution to sites
• •Oversee timely data entry and cleaning
• •Facilitate on-time Data Base Lock
• •Collect and archive required trial documents
• •Identify risks and develop contingency plans
• •Collaborate with project leader on problem-solving
• •Report updates to Trial Leader
• •Participate in quality and process improvement initiatives

Tools & Technologien