Idorsia Pharmaceuticals Ltd
Senior Clinical QA Manager(m/w/x)
Vollzeitnur vor OrtSenior
Basel
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
BEBeOne Medicines I GmbH
Clinical Research Associate(m/w/x)
Basel
ab CHF 92.200 - 115.200 / Jahr
VollzeitVor OrtJunior
Nejo KI-Zusammenfassung
Monitoring oncology/onco-hematology trials in a rapidly growing pharmaceutical company. BS in scientific or healthcare discipline and GCP/ICH knowledge required. Collaboration with study teams, CAPA identification.
Anforderungen
- BS in scientific or healthcare discipline
- Proficiency in Microsoft Word, Excel, PowerPoint, Outlook, laptop, and iPhone
- Knowledge of GCP, ICH, and regulatory guidelines
- Monitoring experience in pharmaceutical or CRO industry (preferred)
- Experience in oncology/onco-hematology trials (preferred)
- Excellent communication and interpersonal skills
- Ability to establish and maintain effective working relationships
- Good organizational and problem-solving skills
- Ability to prioritize and multi-task
- Effective time management skills
- Written and verbal communication skills
- Good command of English language
- Good command of German language
Aufgaben
- Execute clinical monitoring activities
- Monitor clinical trials according to ICH, GCP, and local regulations
- Perform monitoring for oncology/onco-hematology trials
- Collaborate with Country and Regional Clinical Study Teams
- Identify and propose CAPA for gaps and improvements
- Support clinical trial start-up activities
- Complete therapeutic, protocol, and clinical research training
- Gain experience by working with experienced clinical staff
- Conduct site selection and evaluation
- Support initial site list and recruitment targets
- Provide protocol and study training to sites
- Conduct pre-study, initiation, routine monitoring, and closeout visits
- Conduct co-monitoring visits with experienced CRAs
- Create and maintain site management documentation
- Submit regular visit reports and follow-up letters
- Track regulatory submissions, recruitment, and data query resolution
- Manage site documents for TMF and ISF
- Ensure inspection readiness of the study and sites
- Establish regular communication with sites
- Report site progress, issues, and proposed actions
- Collaborate to ensure timely study milestones
- Facilitate Study Compliance Visits and site audits
- Evaluate site practices and escalate issues
- Anticipate and identify site issues
- Propose corrective and preventative actions
- Identify gaps and utilize opportunities
- Strive for operating excellence and innovation
Berufserfahrung
- 1 Jahr
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- Microsoft Word
- Microsoft Excel
- Microsoft PowerPoint
- Microsoft Outlook
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens BeOne Medicines I GmbH 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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BEBeOne Medicines I GmbH
Clinical Research Associate(m/w/x)
Basel
ab CHF 92.200 - 115.200 / Jahr
VollzeitVor OrtJunior
Nejo KI-Zusammenfassung
Monitoring oncology/onco-hematology trials in a rapidly growing pharmaceutical company. BS in scientific or healthcare discipline and GCP/ICH knowledge required. Collaboration with study teams, CAPA identification.
Anforderungen
- BS in scientific or healthcare discipline
- Proficiency in Microsoft Word, Excel, PowerPoint, Outlook, laptop, and iPhone
- Knowledge of GCP, ICH, and regulatory guidelines
- Monitoring experience in pharmaceutical or CRO industry (preferred)
- Experience in oncology/onco-hematology trials (preferred)
- Excellent communication and interpersonal skills
- Ability to establish and maintain effective working relationships
- Good organizational and problem-solving skills
- Ability to prioritize and multi-task
- Effective time management skills
- Written and verbal communication skills
- Good command of English language
- Good command of German language
Aufgaben
- Execute clinical monitoring activities
- Monitor clinical trials according to ICH, GCP, and local regulations
- Perform monitoring for oncology/onco-hematology trials
- Collaborate with Country and Regional Clinical Study Teams
- Identify and propose CAPA for gaps and improvements
- Support clinical trial start-up activities
- Complete therapeutic, protocol, and clinical research training
- Gain experience by working with experienced clinical staff
- Conduct site selection and evaluation
- Support initial site list and recruitment targets
- Provide protocol and study training to sites
- Conduct pre-study, initiation, routine monitoring, and closeout visits
- Conduct co-monitoring visits with experienced CRAs
- Create and maintain site management documentation
- Submit regular visit reports and follow-up letters
- Track regulatory submissions, recruitment, and data query resolution
- Manage site documents for TMF and ISF
- Ensure inspection readiness of the study and sites
- Establish regular communication with sites
- Report site progress, issues, and proposed actions
- Collaborate to ensure timely study milestones
- Facilitate Study Compliance Visits and site audits
- Evaluate site practices and escalate issues
- Anticipate and identify site issues
- Propose corrective and preventative actions
- Identify gaps and utilize opportunities
- Strive for operating excellence and innovation
Berufserfahrung
- 1 Jahr
Ausbildung
- Bachelor-Abschluss
Sprachen
- Englisch – verhandlungssicher
- Deutsch – verhandlungssicher
Tools & Technologien
- Microsoft Word
- Microsoft Excel
- Microsoft PowerPoint
- Microsoft Outlook
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens BeOne Medicines I GmbH 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
BeOne Medicines I GmbH
Branche
Pharmaceuticals
Beschreibung
The company is focused on fighting cancer and offers opportunities for scientific and business professionals.
Noch nicht perfekt?
- Idorsia Pharmaceuticals Ltd
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