Roche Austria GmbH
Country Study Manager(m/w/x)
Vollzeitnur vor OrtSenior
Wien
ab 63.000 / Jahr
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
IQIQVIA
Local Study Associate Director(m/w/x)
Wien
ab 58.500 / Jahr
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Leading local study teams for clinical trials in oncology, rare diseases, cardiology, hematology, or CVRM. Minimum 3 years experience in Development Operations required. On-site work with rotating construction sites.
Anforderungen
- Bachelor degree in related discipline or equivalent qualification
- Minimum 3 years experience in Development Operations or related fields
- Good knowledge of ICH GCP and local regulations
- Ability to lead and motivate cross-functional teams
- Good medical knowledge of Oncology, Rare Diseases, cardiology, hematology, CVRM
- Good knowledge of Drug Development Process
- Excellent understanding of Clinical Study Process including monitoring
- Very good understanding of Study Drug Handling and Data Management
- Excellent project management skills
- Excellent ability to prioritize, handle multiple tasks, attention to details, negotiation skills
- Excellent spoken and written English and German
- Good ability to learn and adapt to IT systems
- Ability to travel nationally and internationally
Aufgaben
- Lead Local Study Teams to deliver clinical studies
- Manage study commitments within the country
- Ensure timely data delivery to required quality
- Lead and optimize Local Study Team performance
- Perform clinical and operational feasibility assessments
- Coordinate site selection and qualification
- Submit applications to EC/IRB and Regulatory Authority
- Prepare and maintain financial Study Management Agreement
- Prepare and update local Master CSA and site budget
- Prepare and manage Master Informed Consent Form
- Collect and verify trial essential documents
- Plan and coordinate local drug activities
- Set up and maintain study in CTMS and local websites
- Oversee and coordinate monitoring activities
- Review monitoring visit reports
- Perform co-monitoring and training visits
- Identify and resolve complex study issues
- Organize Local Study Team meetings
- Build relationships with team members and stakeholders
- Report study progress to Global Study Team
- Contribute to patient recruitment strategy
- Develop and review risk management plan
- Communicate with National Co-ordinating Investigator
- Plan and lead National Investigator meetings
- Prepare study documents for final archiving
- Plan and lead audit and inspection activities
- Provide input to process development
- Inform Line Managers of study milestones
- Update Line Managers on CRA/CSA performance
- Ensure compliance with local policies and ethics
- Provide feedback on research information
- Collaborate with local Medical Affairs team
- Support SMM in various initiatives
Berufserfahrung
- 3 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens IQVIA erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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IQIQVIA
Local Study Associate Director(m/w/x)
Wien
ab 58.500 / Jahr
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Leading local study teams for clinical trials in oncology, rare diseases, cardiology, hematology, or CVRM. Minimum 3 years experience in Development Operations required. On-site work with rotating construction sites.
Anforderungen
- Bachelor degree in related discipline or equivalent qualification
- Minimum 3 years experience in Development Operations or related fields
- Good knowledge of ICH GCP and local regulations
- Ability to lead and motivate cross-functional teams
- Good medical knowledge of Oncology, Rare Diseases, cardiology, hematology, CVRM
- Good knowledge of Drug Development Process
- Excellent understanding of Clinical Study Process including monitoring
- Very good understanding of Study Drug Handling and Data Management
- Excellent project management skills
- Excellent ability to prioritize, handle multiple tasks, attention to details, negotiation skills
- Excellent spoken and written English and German
- Good ability to learn and adapt to IT systems
- Ability to travel nationally and internationally
Aufgaben
- Lead Local Study Teams to deliver clinical studies
- Manage study commitments within the country
- Ensure timely data delivery to required quality
- Lead and optimize Local Study Team performance
- Perform clinical and operational feasibility assessments
- Coordinate site selection and qualification
- Submit applications to EC/IRB and Regulatory Authority
- Prepare and maintain financial Study Management Agreement
- Prepare and update local Master CSA and site budget
- Prepare and manage Master Informed Consent Form
- Collect and verify trial essential documents
- Plan and coordinate local drug activities
- Set up and maintain study in CTMS and local websites
- Oversee and coordinate monitoring activities
- Review monitoring visit reports
- Perform co-monitoring and training visits
- Identify and resolve complex study issues
- Organize Local Study Team meetings
- Build relationships with team members and stakeholders
- Report study progress to Global Study Team
- Contribute to patient recruitment strategy
- Develop and review risk management plan
- Communicate with National Co-ordinating Investigator
- Plan and lead National Investigator meetings
- Prepare study documents for final archiving
- Plan and lead audit and inspection activities
- Provide input to process development
- Inform Line Managers of study milestones
- Update Line Managers on CRA/CSA performance
- Ensure compliance with local policies and ethics
- Provide feedback on research information
- Collaborate with local Medical Affairs team
- Support SMM in various initiatives
Berufserfahrung
- 3 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens IQVIA erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
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?
- Roche Austria GmbH
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Vollzeitnur vor OrtBerufserfahrenWien - AT10 AZ Österreich GmbH
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Vollzeitnur vor OrtBerufserfahrenWienab 81.964 / Jahr