BeOne Medicines Germany GmbH
Clinical Research Associate(m/w/x)
VollzeitRemoteBerufserfahren
Hamburg, Bremen, Berlin
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IQIQVIA Biotech
Clinical Associate Submissions – Regulatory(m/w/x)
Berlin
Vollzeitmit HomeofficeJunior
Nejo KI-Zusammenfassung
Preparing and submitting regulatory documents for clinical trial site activation at biotech and biopharma partners. EU CTR experience for Germany and Austria, plus local language proficiency, required. Diverse clinical development projects across all phases and therapeutic areas.
Anforderungen
- EU CTR experience for Germany and Austria
- Local language proficiency
- Knowledge of national requirements
- B Sc degree in Health Sciences or related field
- 1 - 3 years' relevant clinical research experience
- Experience in EUCTR and CTIS submission procedures
- Feasibility and Country Inform Consent adaptation for DACH regions
- Experience in Site Contract negotiations with DACH sites
- Experience in medical device submissions is beneficial
- In-depth knowledge of clinical systems, procedures, and corporate standards
- Good negotiating and communication skills in local language
- Effective communication, organizational, and interpersonal skills
- Ability to work independently and to effectively prioritize tasks
- Ability to manage multiple projects
- Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
- Understanding of regulated clinical trial environment and knowledge of drug development process
Aufgaben
- Perform country-level tasks for Site Activation activities
- Ensure compliance with local and international regulations
- Adhere to standard operating procedures (SOPs) and project requirements
- Prepare and submit documents to regulatory bodies
- Conduct feasibility and site identification activities
- Manage site activation activities according to regulations and SOPs
- Distribute completed documents to sites and project team members
- Review site documents for completeness and accuracy
- Track and follow up on document approvals and executions
- Inform team members of document completion for individual sites
- Provide local expertise to Site Activation Managers and project teams
- Perform quality control on documents from sites
- Act as a subject matter expert on specific topics
- Mentor junior Clinical Associates
Berufserfahrung
- 1 - 3 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Deutsch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens IQVIA Biotech 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.
Noch nicht perfekt?
- BeOne Medicines Germany GmbH
Senior Clinical Research Associate(m/w/x)
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IQIQVIA Biotech
Clinical Associate Submissions – Regulatory(m/w/x)
Berlin
Vollzeitmit HomeofficeJunior
Nejo KI-Zusammenfassung
Preparing and submitting regulatory documents for clinical trial site activation at biotech and biopharma partners. EU CTR experience for Germany and Austria, plus local language proficiency, required. Diverse clinical development projects across all phases and therapeutic areas.
Anforderungen
- EU CTR experience for Germany and Austria
- Local language proficiency
- Knowledge of national requirements
- B Sc degree in Health Sciences or related field
- 1 - 3 years' relevant clinical research experience
- Experience in EUCTR and CTIS submission procedures
- Feasibility and Country Inform Consent adaptation for DACH regions
- Experience in Site Contract negotiations with DACH sites
- Experience in medical device submissions is beneficial
- In-depth knowledge of clinical systems, procedures, and corporate standards
- Good negotiating and communication skills in local language
- Effective communication, organizational, and interpersonal skills
- Ability to work independently and to effectively prioritize tasks
- Ability to manage multiple projects
- Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
- Understanding of regulated clinical trial environment and knowledge of drug development process
Aufgaben
- Perform country-level tasks for Site Activation activities
- Ensure compliance with local and international regulations
- Adhere to standard operating procedures (SOPs) and project requirements
- Prepare and submit documents to regulatory bodies
- Conduct feasibility and site identification activities
- Manage site activation activities according to regulations and SOPs
- Distribute completed documents to sites and project team members
- Review site documents for completeness and accuracy
- Track and follow up on document approvals and executions
- Inform team members of document completion for individual sites
- Provide local expertise to Site Activation Managers and project teams
- Perform quality control on documents from sites
- Act as a subject matter expert on specific topics
- Mentor junior Clinical Associates
Berufserfahrung
- 1 - 3 Jahre
Ausbildung
- Bachelor-Abschluss
Sprachen
- Deutsch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens IQVIA Biotech 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.
Über das Unternehmen
IQVIA Biotech
Branche
Healthcare
Beschreibung
The company partners with biotech and emerging biopharma companies to support clinical development across all phases and therapeutic areas.
Noch nicht perfekt?
- BeOne Medicines Germany GmbH
Clinical Research Associate(m/w/x)
VollzeitRemoteBerufserfahrenHamburg, Bremen, Berlin - BeOne Medicines Germany GmbH
Senior Clinical Research Associate(m/w/x)
VollzeitRemoteSeniorHamburg, Bremen, Berlin - Clinische Studien Gesellschaft (CSG)
Clinical Research Associate / Klinischer Monitor(m/w/x)
Vollzeitmit HomeofficeBerufserfahrenBerlin - Immatics Biotechnologies GmbH
Medical Monitor*(m/w/x)
Vollzeit/Teilzeitmit HomeofficeBerufserfahrenTübingen, München, Berlin - Takeda
Associate Director, Study Site Engagement(m/w/x)
Vollzeitmit HomeofficeSeniorBerlin