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Local Trial Manager - Sponsor Dedicated(m/w/x)
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
Berufserfahrung
- 5 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- GCP
- ICH guidelines
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- AOP HealthVollzeitmit HomeofficeSeniorWienab 45.080 / Jahr
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Clinical Trial Manager(m/w/x)
VollzeitRemoteBerufserfahrenWien - IQVIA
Clinical Research Associate II or Senior Clinical Research Associate I(m/w/x)
Vollzeitmit HomeofficeSeniorWienab 4.200 / Monat - IQVIA Biotech
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Local Trial Manager - Sponsor Dedicated(m/w/x)
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
Berufserfahrung
- 5 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- GCP
- ICH guidelines
Über das Unternehmen
IQVIA
Branche
Healthcare
Beschreibung
IQVIA is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients.
Noch nicht perfekt?
- AOP Health
Clinical Site Management Lead(m/w/x)
Vollzeitmit HomeofficeSeniorWienab 45.080 / Jahr - IQVIA Biotech
Clinical Research Associate 2(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenWienab 4.000 / Monat - ICON plc
Clinical Trial Manager(m/w/x)
VollzeitRemoteBerufserfahrenWien - IQVIA
Clinical Research Associate II or Senior Clinical Research Associate I(m/w/x)
Vollzeitmit HomeofficeSeniorWienab 4.200 / Monat - IQVIA Biotech
Clinical Associate Regulatory Submissions(m/w/x)
Vollzeitmit HomeofficeJuniorWien