Local Trial Manager - Sponsor Dedicated(m/w/x)

Beschreibung

Country-level oversight of oncology clinical trials including budget proposals and external service provider contract management. Minimum 5 years clinical research and 1-3 years local trial management experience required. Primary point of contact for site-specific regulatory compliance and GCP adherence.

Anforderungen

• •Master’s or higher-level life science degree
• •5 years clinical research experience
• •1-3 years local trial management experience
• •Therapeutic area expertise in Oncology
• •Knowledge of GCP and ICH guidelines
• •Fluent German and good English command
• •Strong IT and software skills
• •Decision-making and financial management skills
• •Flexibility and virtual team management
• •Willingness to travel occasionally

Aufgaben

• •Adhere to SOPs, GCP codes, and local regulatory requirements
• •Prepare high-level and detailed budget proposals
• •Manage external service provider contracts and change orders
• •Ensure services are delivered according to contract terms
• •Act as the primary country-level contact for assigned trials
• •Track project progress against planned timelines
• •Monitor patient recruitment to meet enrollment targets
• •Maintain and update trial management systems
• •Analyze trial progress using study tools and reports
• •Prepare for and conduct Health Authority inspections
• •Support internal Quality Assurance audits
• •Develop site-level recruitment strategies and contingency plans
• •Manage country-level vendors to support study execution
• •Submit requests for and assist in vendor selection
• •Review country-specific informed consent documents
• •Report AEs, SAEs, and PQCs within required timelines
• •Maintain accurate data in CTMS and VTMF systems
• •Ensure inspection readiness and document archiving compliance
• •Implement CAPAs for audits and quality issues
• •Collaborate with Global Trial and Clinical Project Leads
• •Forecast and manage local trial budgets proactively
• •Ensure accurate and timely finance reporting
• •Negotiate trial site contracts and budgets
• •Organize and secure IEC and Health Authority approvals
• •Mentor staff or represent functional areas in process initiatives

Tools & Technologien