Revolution Medicines
Director, CMC Regulatory, Europe(m/w/x)
Vollzeitmit HomeofficeManagement
Basel
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Country-level site activation for clinical trials in the life sciences industry. German fluency and 3 years' clinical research experience required. Single point of contact for investigative sites and internal teams.
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Anforderungen
- German language fluency
- Bachelor’s Degree in life sciences or related field and 3 years’ clinical research or relevant experience; or equivalent education, training, and experience
- In-depth knowledge of clinical systems, procedures, and corporate standards
- Knowledge and ability to apply GCP/ICH and regulatory guidelines
- Knowledge of applicable regulatory requirements, local regulations, SOPs, and corporate standards
- Understanding of regulated clinical trial environment and drug development process
Aufgaben
- Perform country-level site activation tasks per regulations, SOPs, project requirements, and budget guidelines
- Perform site activation maintenance activities
- Serve as Single Point of Contact for investigative sites and internal teams
- Ensure adherence to SOPs, Work Instructions, and quality standards
- Ensure adherence to project timelines
- Perform start-up and site activation activities according to regulations and work instructions
- Distribute completed documents to sites and internal teams
- Prepare and review site regulatory documents for completeness and accuracy
- Ensure accurate completion and maintenance of internal systems and databases
- Review site performance metrics and provide feedback to management
- Review, establish, and agree on project planning and timelines
- Ensure monitoring measures are in place
- Implement contingency plans as needed
- Inform team members of regulatory and contractual document completion for sites
- Review, track, and follow up on document progress, approval, and execution
- Manage regulatory, ethics, ICF, and IP release documents in line with project timelines
- Provide local expertise to SAMs and project teams during timeline planning
- Perform quality control of documents provided by sites
- Contact sponsors on specific initiatives
Berufserfahrung
3 Jahre
Ausbildung
Bachelor-Abschluss
Sprachen
Deutsch – fließend
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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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IQ
PharmaceuticalsBasel
IQVIA is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients.
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