Beschreibung

As a Local Trial Manager, you will oversee clinical trials from home in Germany, ensuring compliance, managing budgets, and driving patient recruitment while collaborating with various teams to achieve research goals.

Anforderungen

• •Master’s or higher-level degree in life science
• •Minimum of 5 years of clinical research experience in the pharmaceutical industry or CRO plus 1-3 years of local clinical trial management experience
• •Therapeutic area expertise in Oncology
• •Strong working knowledge of clinical research regulatory requirements, i.e., GCP and ICH guidelines
• •Fluent language skills in German on at least C1 level and good command of English
• •Strong IT skills in appropriate software and company systems
• •Excellent decision-making and strong financial management skills
• •Flexibility and ability to manage study teams in a virtual environment
• •Willingness to travel occasionally for business meetings

Aufgaben

• •Prepare high-level budget estimates for service requests
• •Develop detailed budget proposals
• •Manage contracts and review external service provider agreements
• •Act as the primary contact for assigned trials at the country level
• •Track project progress against planned timelines
• •Monitor patient recruitment rates to meet enrollment targets
• •Maintain and update trial management systems
• •Analyze trial progress using management reports
• •Participate in Health Authority inspections and internal audits
• •Contribute to site-level recruitment strategies and contingency plans
• •Manage vendor services and support vendor selection
• •Review country-specific informed consent documents
• •Ensure timely reporting of adverse events and serious adverse events
• •Maintain accurate trial data and essential documents
• •Collaborate with Global Trial Lead on quality issues
• •Ensure accurate financial reporting and budget adherence
• •Organize IEC/HA approvals to comply with local regulations
• •Mentor or represent the functional area in process initiatives

Tools & Technologien