85 Jobs für Trial Management in Österreich
Regional Clinical Trial Manager (m/f/d)
Vienna, Wien
Boehringer Ingelheim
Vor 4 Tagen gepostet
Job angesehen
Arbeitsbeschreibung
**The position**
For our Regional Therapeutic Area Management Group in Clinical Development & Operations we are looking for a Clinical Trial Manager (f/m/d) as of now. You will provide operational expertise to manage and oversee clinical trials conducted in different therapeutic areas that are under the management of the RCV (Regional Center Vienna) office.
**Tasks & responsibilities**
+ Manage and coordinate international clinical trial preparation and conduct in the region, execute clinical trial plans; manage and account for trial deliverables (data, quality, timelines, budget) within the region
+ Establish, actively maintain and supervise relationships with investigators
+ Counsel and guide the regional, cross-functional trial team, incl. Clinical Research Associates (CRAs) and assigned Contract Research Organizations' (CROs) staff
+ Review trial related documents/reports, and ensure timely submission to Ethic Committees and Competent Authorities
+ Train and functionally lead the trial coordinators and CRAs, supervise monitoring activities and perform Co-Monitoring visits, lead and conduct investigator meetings
**Requirements**
+ Academic qualification: MD or biological/natural science
+ Prior experience in clinical research; at least 3 years as on-site monitor (CRA); experience in project/trial management as well as leadership potential is an asset
+ Thorough knowledge of international and national/regional guidelines and regulatory topics and familiar with the end-to-end clinical trial process including the interfaces
+ Demonstrate collaboration skills, able to work in a cross-functional matrix environment, ability to prioritize and make decisions
+ Excellent interpersonal, communication, organization, and coordination skills in written and spoken English
Please note that employment takes place via one of our external partners. The employment takes place exclusively at Boehringer Ingelheim RCV GmbH & Co KG.
**Your Benefits**
+ **Flexible working time models:** home office and flexible working hours, depending on department and position - many things are possible with us.
+ **Additional days off ("bridge-days"):** more free time through additional days off to bridge single working days between bank holidays and the weekend - without having to use vacation days.
+ **Canteen & Cafeteria:** whether it's coffee and croissant for breakfast, various lunch menus or snacks in between - our subsidized staff restaurant & cafeteria has something for every taste including vegetarian and vegan options.
+ **Learning & development:** diverse training and development opportunities for your personal and professional growth. Because: you never stop learning.
+ **Health promotion:** health is important to us - that's why we offer different programs to promote physical and mental health.
+ **Public transport ticket:** we encourage our employees to use public transport on their daily way to work. Costs for public transport? We cover them!
The remuneration for this position starts at EUR 68.000 gross annual target salary per year (full time). The actual salary package depends on professional experience and qualifications. We will be happy to discuss further details in person.
**We are looking forward to receiving your application online!**
By uploading your application documents via our application portal, we can treat your data confidentially and in compliance with the GDPR.
Do you have any additional questions about the position? Your HR Recruiting Manager for this position is Katrin Spögler
On our career site ( you will find further information about Boehringer Ingelheim as an employer as well as information about the application process and our different departments.
Would you like to know what makes our employees special? What they tell about their motivation and their everyday work? Watch this video ( and hear for yourself what our colleagues have to share.
All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
For our Regional Therapeutic Area Management Group in Clinical Development & Operations we are looking for a Clinical Trial Manager (f/m/d) as of now. You will provide operational expertise to manage and oversee clinical trials conducted in different therapeutic areas that are under the management of the RCV (Regional Center Vienna) office.
**Tasks & responsibilities**
+ Manage and coordinate international clinical trial preparation and conduct in the region, execute clinical trial plans; manage and account for trial deliverables (data, quality, timelines, budget) within the region
+ Establish, actively maintain and supervise relationships with investigators
+ Counsel and guide the regional, cross-functional trial team, incl. Clinical Research Associates (CRAs) and assigned Contract Research Organizations' (CROs) staff
+ Review trial related documents/reports, and ensure timely submission to Ethic Committees and Competent Authorities
+ Train and functionally lead the trial coordinators and CRAs, supervise monitoring activities and perform Co-Monitoring visits, lead and conduct investigator meetings
**Requirements**
+ Academic qualification: MD or biological/natural science
+ Prior experience in clinical research; at least 3 years as on-site monitor (CRA); experience in project/trial management as well as leadership potential is an asset
+ Thorough knowledge of international and national/regional guidelines and regulatory topics and familiar with the end-to-end clinical trial process including the interfaces
+ Demonstrate collaboration skills, able to work in a cross-functional matrix environment, ability to prioritize and make decisions
+ Excellent interpersonal, communication, organization, and coordination skills in written and spoken English
Please note that employment takes place via one of our external partners. The employment takes place exclusively at Boehringer Ingelheim RCV GmbH & Co KG.
**Your Benefits**
+ **Flexible working time models:** home office and flexible working hours, depending on department and position - many things are possible with us.
+ **Additional days off ("bridge-days"):** more free time through additional days off to bridge single working days between bank holidays and the weekend - without having to use vacation days.
+ **Canteen & Cafeteria:** whether it's coffee and croissant for breakfast, various lunch menus or snacks in between - our subsidized staff restaurant & cafeteria has something for every taste including vegetarian and vegan options.
+ **Learning & development:** diverse training and development opportunities for your personal and professional growth. Because: you never stop learning.
+ **Health promotion:** health is important to us - that's why we offer different programs to promote physical and mental health.
+ **Public transport ticket:** we encourage our employees to use public transport on their daily way to work. Costs for public transport? We cover them!
The remuneration for this position starts at EUR 68.000 gross annual target salary per year (full time). The actual salary package depends on professional experience and qualifications. We will be happy to discuss further details in person.
**We are looking forward to receiving your application online!**
By uploading your application documents via our application portal, we can treat your data confidentially and in compliance with the GDPR.
Do you have any additional questions about the position? Your HR Recruiting Manager for this position is Katrin Spögler
On our career site ( you will find further information about Boehringer Ingelheim as an employer as well as information about the application process and our different departments.
Would you like to know what makes our employees special? What they tell about their motivation and their everyday work? Watch this video ( and hear for yourself what our colleagues have to share.
All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
Leider ist dieser Job in Ihrer Region nicht verfügbar
0
Clinical Research Manager
Innsbruck, Tirol
MED-EL Medical Electronics
Heute
Job angesehen
Arbeitsbeschreibung
RDEA_32508
Clinical Research Manager (m/f/d) Clinical Research
Innsbruck, Austria
Professionals
Full-Time 38.5h
Permanent
Apply Now
Your Tasks
Planning, execution, and completion of clinical studies in accordance with applicable regulations (MDR, Declaration of Helsinki, ISO 14155)
Coordination and management of multicenter applications with authorities and ethics committees, including document preparation and administration for pre- and post-market studies
Contribution to scientific publications and publication strategy, including storyline development
Preparation and management of safety reports
Participation in project teams for process optimization, documentation improvement, and data preparation
Your Profile
Masters' degree or higher degree (University, FH) in Life Sciences
At least 2 years of professional experience as a Clinical Research Manager, ideally in the field of medical devices
Good knowledge of regulatory requirements in medical technology
Experience with MS Office, review tools, reference management, and document management is an advantage
Very good command of English, both written and spoken; basic knowledge of the German language is required
Your Benefits
Central Location
Employee Discounts
Flexible Hours
International Environment
Onboarding
Workplace Well-Being
Further information
Minimum Salary
Salary will be determined based on professional experience; the formal minimum salary according to Collective Bargaining Agreement is € 46,781.00.
Earliest Entry Date
This position is to be filled immediately.
Your Contact Person
If you have any questions please contact Marina Engl.
Email ›
Want to join a company that helps bring the joy of sound to people with hearing loss? Apply now
MED-EL Medical Electronics
Fürstenweg 77a | 6020 Innsbruck, Austria |
medel.com
Clinical Research Manager (m/f/d) Clinical Research
Innsbruck, Austria
Professionals
Full-Time 38.5h
Permanent
Apply Now
Your Tasks
Planning, execution, and completion of clinical studies in accordance with applicable regulations (MDR, Declaration of Helsinki, ISO 14155)
Coordination and management of multicenter applications with authorities and ethics committees, including document preparation and administration for pre- and post-market studies
Contribution to scientific publications and publication strategy, including storyline development
Preparation and management of safety reports
Participation in project teams for process optimization, documentation improvement, and data preparation
Your Profile
Masters' degree or higher degree (University, FH) in Life Sciences
At least 2 years of professional experience as a Clinical Research Manager, ideally in the field of medical devices
Good knowledge of regulatory requirements in medical technology
Experience with MS Office, review tools, reference management, and document management is an advantage
Very good command of English, both written and spoken; basic knowledge of the German language is required
Your Benefits
Central Location
Employee Discounts
Flexible Hours
International Environment
Onboarding
Workplace Well-Being
Further information
Minimum Salary
Salary will be determined based on professional experience; the formal minimum salary according to Collective Bargaining Agreement is € 46,781.00.
Earliest Entry Date
This position is to be filled immediately.
Your Contact Person
If you have any questions please contact Marina Engl.
Email ›
Want to join a company that helps bring the joy of sound to people with hearing loss? Apply now
MED-EL Medical Electronics
Fürstenweg 77a | 6020 Innsbruck, Austria |
medel.com
Leider ist dieser Job in Ihrer Region nicht verfügbar
1
Clinical Research Manager (M/F/D)
6080 Innsbruck, Tirol
MED-EL Medical Electronics
Heute
Job angesehen
Arbeitsbeschreibung
RDEA_32508 Clinical Research Manager (m/f/d) Clinical ResearchInnsbruck, AustriaProfessionalsFull-Time 38.5hPermanentApply NowYour TasksPlanning, execution, and completion of clinical studies in accordance with applicable regulations (MDR, Declaration of Helsinki, ISO 14155)Coordination and management of multicenter applications with authorities and ethics committees, including document preparation and administration for pre- and post-market studiesContribution to scientific publications and publication strategy, including storyline developmentPreparation and management of safety reportsParticipation in project teams for process optimization, documentation improvement, and data preparationYour ProfileMasters’ degree or higher degree (University, FH) in Life SciencesAt least 2 years of professional experience as a Clinical Research Manager, ideally in the field of medical devicesGood knowledge of regulatory requirements in medical technologyExperience with MS Office, review tools, reference management, and document management is an advantageVery good command of English, both written and spoken;
basic knowledge of the German language is requiredYour Benefits Central Location Employee Discounts Flexible Hours International Environment Onboarding Workplace Well-Being Further informationMinimum SalarySalary will be determined based on professional experience;
the formal minimum salary according to Collective Bargaining Agreement is € 46,781.00.Earliest Entry DateThis position is to be filled immediately.Your Contact PersonIf you have any questions please contact Marina Engl.Email › Want to join a company that helps bring the joy of sound to people with hearing loss? Apply now! MED-EL Medical Electronics Fürstenweg 77a | 6020 Innsbruck, Austria |
basic knowledge of the German language is requiredYour Benefits Central Location Employee Discounts Flexible Hours International Environment Onboarding Workplace Well-Being Further informationMinimum SalarySalary will be determined based on professional experience;
the formal minimum salary according to Collective Bargaining Agreement is € 46,781.00.Earliest Entry DateThis position is to be filled immediately.Your Contact PersonIf you have any questions please contact Marina Engl.Email › Want to join a company that helps bring the joy of sound to people with hearing loss? Apply now! MED-EL Medical Electronics Fürstenweg 77a | 6020 Innsbruck, Austria |
Leider ist dieser Job in Ihrer Region nicht verfügbar
2
Clinical research manager (m/f/d)
Innsbruck, Tirol
MED-EL Medical Electronics
Heute
Job angesehen
Arbeitsbeschreibung
RDEA_32508
Clinical Research Manager (m/f/d) Clinical Research
Innsbruck, Austria
Professionals
Full-Time 38.5h
Permanent
Apply Now
Your Tasks
Planning, execution, and completion of clinical studies in accordance with applicable regulations (MDR, Declaration of Helsinki, ISO 14155)
Coordination and management of multicenter applications with authorities and ethics committees, including document preparation and administration for pre- and post-market studies
Contribution to scientific publications and publication strategy, including storyline development
Preparation and management of safety reports
Participation in project teams for process optimization, documentation improvement, and data preparation
Your Profile
Masters’ degree or higher degree (University, FH) in Life Sciences
At least 2 years of professional experience as a Clinical Research Manager, ideally in the field of medical devices
Good knowledge of regulatory requirements in medical technology
Experience with MS Office, review tools, reference management, and document management is an advantage
Very good command of English, both written and spoken; basic knowledge of the German language is required
Your Benefits
Central Location
Employee Discounts
Flexible Hours
International Environment
Onboarding
Workplace Well-Being
Further information
Minimum Salary
Salary will be determined based on professional experience; the formal minimum salary according to Collective Bargaining Agreement is € 46,781.00.
Earliest Entry Date
This position is to be filled immediately.
Your Contact Person
If you have any questions please contact Marina Engl.
Email ›
Want to join a company that helps bring the joy of sound to people with hearing loss? Apply now!
MED-EL Medical Electronics
Fürstenweg 77a | 6020 Innsbruck, Austria |
medel.com
Clinical Research Manager (m/f/d) Clinical Research
Innsbruck, Austria
Professionals
Full-Time 38.5h
Permanent
Apply Now
Your Tasks
Planning, execution, and completion of clinical studies in accordance with applicable regulations (MDR, Declaration of Helsinki, ISO 14155)
Coordination and management of multicenter applications with authorities and ethics committees, including document preparation and administration for pre- and post-market studies
Contribution to scientific publications and publication strategy, including storyline development
Preparation and management of safety reports
Participation in project teams for process optimization, documentation improvement, and data preparation
Your Profile
Masters’ degree or higher degree (University, FH) in Life Sciences
At least 2 years of professional experience as a Clinical Research Manager, ideally in the field of medical devices
Good knowledge of regulatory requirements in medical technology
Experience with MS Office, review tools, reference management, and document management is an advantage
Very good command of English, both written and spoken; basic knowledge of the German language is required
Your Benefits
Central Location
Employee Discounts
Flexible Hours
International Environment
Onboarding
Workplace Well-Being
Further information
Minimum Salary
Salary will be determined based on professional experience; the formal minimum salary according to Collective Bargaining Agreement is € 46,781.00.
Earliest Entry Date
This position is to be filled immediately.
Your Contact Person
If you have any questions please contact Marina Engl.
Email ›
Want to join a company that helps bring the joy of sound to people with hearing loss? Apply now!
MED-EL Medical Electronics
Fürstenweg 77a | 6020 Innsbruck, Austria |
medel.com
Leider ist dieser Job in Ihrer Region nicht verfügbar
3
Clinical Research Manager (m/f/d)
Innsbruck, Tirol
MED-EL Medical Electronics
Vor 3 Tagen gepostet
Job angesehen
Arbeitsbeschreibung
RDEA_32508
Clinical Research Manager (m/f/d) Clinical Research
Innsbruck, Austria
Professionals
Full-Time 38.5h
Permanent
Apply Now
Your Tasks
Planning, execution, and completion of clinical studies in accordance with applicable regulations (MDR, Declaration of Helsinki, ISO 14155)
Coordination and management of multicenter applications with authorities and ethics committees, including document preparation and administration for pre- and post-market studies
Contribution to scientific publications and publication strategy, including storyline development
Preparation and management of safety reports
Participation in project teams for process optimization, documentation improvement, and data preparation
Your Profile
Masters’ degree or higher degree (University, FH) in Life Sciences
At least 2 years of professional experience as a Clinical Research Manager, ideally in the field of medical devices
Good knowledge of regulatory requirements in medical technology
Experience with MS Office, review tools, reference management, and document management is an advantage
Very good command of English, both written and spoken; basic knowledge of the German language is required
Your Benefits
Central Location
Employee Discounts
Flexible Hours
International Environment
Onboarding
Workplace Well-Being
Further information
Minimum Salary
Salary will be determined based on professional experience; the formal minimum salary according to Collective Bargaining Agreement is € 46,781.00.
Earliest Entry Date
This position is to be filled immediately.
Your Contact Person
If you have any questions please contact Marina Engl.
Email ›
Want to join a company that helps bring the joy of sound to people with hearing loss? Apply now!
MED-EL Medical Electronics
Fürstenweg 77a | 6020 Innsbruck, Austria |
medel.com
Clinical Research Manager (m/f/d) Clinical Research
Innsbruck, Austria
Professionals
Full-Time 38.5h
Permanent
Apply Now
Your Tasks
Planning, execution, and completion of clinical studies in accordance with applicable regulations (MDR, Declaration of Helsinki, ISO 14155)
Coordination and management of multicenter applications with authorities and ethics committees, including document preparation and administration for pre- and post-market studies
Contribution to scientific publications and publication strategy, including storyline development
Preparation and management of safety reports
Participation in project teams for process optimization, documentation improvement, and data preparation
Your Profile
Masters’ degree or higher degree (University, FH) in Life Sciences
At least 2 years of professional experience as a Clinical Research Manager, ideally in the field of medical devices
Good knowledge of regulatory requirements in medical technology
Experience with MS Office, review tools, reference management, and document management is an advantage
Very good command of English, both written and spoken; basic knowledge of the German language is required
Your Benefits
Central Location
Employee Discounts
Flexible Hours
International Environment
Onboarding
Workplace Well-Being
Further information
Minimum Salary
Salary will be determined based on professional experience; the formal minimum salary according to Collective Bargaining Agreement is € 46,781.00.
Earliest Entry Date
This position is to be filled immediately.
Your Contact Person
If you have any questions please contact Marina Engl.
Email ›
Want to join a company that helps bring the joy of sound to people with hearing loss? Apply now!
MED-EL Medical Electronics
Fürstenweg 77a | 6020 Innsbruck, Austria |
medel.com
Leider ist dieser Job in Ihrer Region nicht verfügbar
4
Clinical Research Manager (m/f/d)
Innsbruck, Tirol
MED-EL Medical Electronics
Vor 2 Tagen gepostet
Job angesehen
Arbeitsbeschreibung
RDEA_32508
Clinical Research Manager (m/f/d) Clinical Research
Innsbruck, Austria
Professionals
Full-Time 38.5h
Permanent
Apply Now
Your Tasks
Planning, execution, and completion of clinical studies in accordance with applicable regulations (MDR, Declaration of Helsinki, ISO 14155)
Coordination and management of multicenter applications with authorities and ethics committees, including document preparation and administration for pre- and post-market studies
Contribution to scientific publications and publication strategy, including storyline development
Preparation and management of safety reports
Participation in project teams for process optimization, documentation improvement, and data preparation
Your Profile
Masters’ degree or higher degree (University, FH) in Life Sciences
At least 2 years of professional experience as a Clinical Research Manager, ideally in the field of medical devices
Good knowledge of regulatory requirements in medical technology
Experience with MS Office, review tools, reference management, and document management is an advantage
Very good command of English, both written and spoken; basic knowledge of the German language is required
Your Benefits
Central Location
Employee Discounts
Flexible Hours
International Environment
Onboarding
Workplace Well-Being
Further information
Minimum Salary
Salary will be determined based on professional experience; the formal minimum salary according to Collective Bargaining Agreement is € 46,781.00.
Earliest Entry Date
This position is to be filled immediately.
Your Contact Person
If you have any questions please contact Marina Engl.
Email ›
Want to join a company that helps bring the joy of sound to people with hearing loss? Apply now!
MED-EL Medical Electronics
Fürstenweg 77a | 6020 Innsbruck, Austria |
medel.com
Leider ist dieser Job in Ihrer Region nicht verfügbar
5
▷ Jetzt bewerben: Clinical Research Manager (m/f/d)
Innsbruck, Tirol
MED-EL Medical Electronics
Heute
Job angesehen
Arbeitsbeschreibung
RDEA_32508
Clinical Research Manager (m/f/d) Clinical Research
Innsbruck, Austria
Professionals
Full-Time 38.5h
Permanent
Apply Now
Your Tasks
Planning, execution, and completion of clinical studies in accordance with applicable regulations (MDR, Declaration of Helsinki, ISO 14155)
Coordination and management of multicenter applications with authorities and ethics committees, including document preparation and administration for pre- and post-market studies
Contribution to scientific publications and publication strategy, including storyline development
Preparation and management of safety reports
Participation in project teams for process optimization, documentation improvement, and data preparation
Your Profile
Masters’ degree or higher degree (University, FH) in Life Sciences
At least 2 years of professional experience as a Clinical Research Manager, ideally in the field of medical devices
Good knowledge of regulatory requirements in medical technology
Experience with MS Office, review tools, reference management, and document management is an advantage
Very good command of English, both written and spoken; basic knowledge of the German language is required
Your Benefits
Central Location
Employee Discounts
Flexible Hours
International Environment
Onboarding
Workplace Well-Being
Further information
Minimum Salary
Salary will be determined based on professional experience; the formal minimum salary according to Collective Bargaining Agreement is € 46,781.00.
Earliest Entry Date
This position is to be filled immediately.
Your Contact Person
If you have any questions please contact Marina Engl.
Email ›
Want to join a company that helps bring the joy of sound to people with hearing loss? Apply now!
MED-EL Medical Electronics
Fürstenweg 77a | 6020 Innsbruck, Austria |
medel.com
Leider ist dieser Job in Ihrer Region nicht verfügbar
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6
Clinical Research Associate (Remote)
4020 Linz, Oberösterreich
WhatJobs
Heute
Job angesehen
Arbeitsbeschreibung
Unser Klient, ein führendes Unternehmen im Bereich der biopharmazeutischen Forschung, sucht einen erfahrenen Clinical Research Associate (CRA) für sein virtuelles Team. In dieser Rolle sind Sie für die Überwachung und Koordination klinischer Studienprojekte verantwortlich und stellen sicher, dass diese gemäß den Protokollen, GCP (Good Clinical Practice) und geltenden regulatorischen Anforderungen durchgeführt werden. Sie arbeiten remote und interagieren hauptsächlich virtuell mit Prüfzentren, Sponsoren und anderen Stakeholdern, um die Datenerfassung, die Patientensicherheit und die Studienintegrität zu gewährleisten.
Ihre Hauptaufgaben umfassen die Auswahl und Qualifizierung von Prüfzentren, die Initiierung von Studien, die regelmäßige Überwachung von Studienaktivitäten vor Ort (virtuell oder bei Bedarf persönlich), die Sicherstellung der Einhaltung von Protokollen und regulatorischen Richtlinien, die Verwaltung von Studienunterlagen und die Erstellung von Berichten. Sie sind die primäre Anlaufstelle für Prüfärzte und Studienpersonal in Bezug auf studienbezogene Fragen und Probleme. Die Identifizierung und Lösung von Problemen, die während der Durchführung einer Studie auftreten, gehört ebenfalls zu Ihrem Verantwortungsbereich.
Wir erwarten von Ihnen einen Hochschulabschluss in einem naturwissenschaftlichen oder gesundheitsbezogenen Bereich (z.B. Biologie, Pharmazie, Medizin) und mindestens 3 Jahre Erfahrung als CRA. Umfassende Kenntnisse der GCP-Richtlinien und anderer relevanter regulatorischer Anforderungen (z.B. ICH-GCP) sind unerlässlich. Sie müssen über ausgeprägte analytische Fähigkeiten, Detailgenauigkeit und hervorragende organisatorische Fähigkeiten verfügen. Exzellente Kommunikations- und zwischenmenschliche Fähigkeiten sind entscheidend, da Sie eng mit einem verteilten Team und verschiedenen Interessengruppen zusammenarbeiten. Die Fähigkeit, selbstständig und ergebnisorientiert zu arbeiten, ist eine Grundvoraussetzung für diese remote Position. Fundierte Kenntnisse in elektronischen Datenmanagementsystemen (EDC) und Studiendokumentationssystemen sind von Vorteil. Da diese Stelle vollständig remote ausgeführt wird, sind eine zuverlässige Internetverbindung und die Fähigkeit, effektiv in einem virtuellen Umfeld zu arbeiten, unerlässlich. Sie werden Teil eines globalen Teams und tragen aktiv zum Erfolg wichtiger medizinischer Forschungsprojekte bei. Das Arbeitsumfeld ist anspruchsvoll, aber auch sehr bereichernd, da Sie direkt zur Entwicklung neuer Therapien beitragen.
Ihre Hauptaufgaben umfassen die Auswahl und Qualifizierung von Prüfzentren, die Initiierung von Studien, die regelmäßige Überwachung von Studienaktivitäten vor Ort (virtuell oder bei Bedarf persönlich), die Sicherstellung der Einhaltung von Protokollen und regulatorischen Richtlinien, die Verwaltung von Studienunterlagen und die Erstellung von Berichten. Sie sind die primäre Anlaufstelle für Prüfärzte und Studienpersonal in Bezug auf studienbezogene Fragen und Probleme. Die Identifizierung und Lösung von Problemen, die während der Durchführung einer Studie auftreten, gehört ebenfalls zu Ihrem Verantwortungsbereich.
Wir erwarten von Ihnen einen Hochschulabschluss in einem naturwissenschaftlichen oder gesundheitsbezogenen Bereich (z.B. Biologie, Pharmazie, Medizin) und mindestens 3 Jahre Erfahrung als CRA. Umfassende Kenntnisse der GCP-Richtlinien und anderer relevanter regulatorischer Anforderungen (z.B. ICH-GCP) sind unerlässlich. Sie müssen über ausgeprägte analytische Fähigkeiten, Detailgenauigkeit und hervorragende organisatorische Fähigkeiten verfügen. Exzellente Kommunikations- und zwischenmenschliche Fähigkeiten sind entscheidend, da Sie eng mit einem verteilten Team und verschiedenen Interessengruppen zusammenarbeiten. Die Fähigkeit, selbstständig und ergebnisorientiert zu arbeiten, ist eine Grundvoraussetzung für diese remote Position. Fundierte Kenntnisse in elektronischen Datenmanagementsystemen (EDC) und Studiendokumentationssystemen sind von Vorteil. Da diese Stelle vollständig remote ausgeführt wird, sind eine zuverlässige Internetverbindung und die Fähigkeit, effektiv in einem virtuellen Umfeld zu arbeiten, unerlässlich. Sie werden Teil eines globalen Teams und tragen aktiv zum Erfolg wichtiger medizinischer Forschungsprojekte bei. Das Arbeitsumfeld ist anspruchsvoll, aber auch sehr bereichernd, da Sie direkt zur Entwicklung neuer Therapien beitragen.
Leider ist dieser Job in Ihrer Region nicht verfügbar
7
Senior Pharmacist - Clinical Research
6300 Kufstein District, Tirol
WhatJobs
Gestern
Job angesehen
Arbeitsbeschreibung
Für unseren Klienten, ein führendes Unternehmen in der Pharmaindustrie mit Sitz in der Nähe von Kufstein, Tyrol, AT , suchen wir eine/n hochqualifizierte/n Senior Pharmacist für die klinische Forschung. Diese Position ist **vollständig remote** und bietet Ihnen die Flexibilität, von überall aus zu arbeiten.
Ihre Aufgaben:
Ihre Aufgaben:
- Überwachung und Steuerung klinischer Studien gemäß GCP-Richtlinien und lokalen Vorschriften.
- Entwicklung und Implementierung von Studienprotokollen und zugehörigen Dokumenten.
- Betreuung von Prüfzentren und Sicherstellung der ordnungsgemäßen Durchführung der Studien.
- Datenerfassung, -analyse und -interpretation zur Bewertung der Wirksamkeit und Sicherheit von neuen Arzneimitteln.
- Erstellung von Berichten und Präsentationen für interne Stakeholder und externe Aufsichtsbehörden.
- Schulung von Studienpersonal und anderen medizinischen Fachkräften.
- Sicherstellung der Einhaltung von Qualitätsstandards und regulatorischen Anforderungen.
- Identifizierung und Management von Risiken im Zusammenhang mit klinischen Studien.
- Aktive Teilnahme an Projektmeetings und Zusammenarbeit mit interdisziplinären Teams.
- Kontinuierliche Weiterbildung und Informationsaustausch über neueste wissenschaftliche Erkenntnisse und Entwicklungen im Bereich der pharmazeutischen Forschung.
- Abgeschlossenes Pharmaziestudium und Approbation als Apotheker/in.
- Mehrjährige Berufserfahrung in der klinischen Forschung, idealerweise in der Pharmaindustrie.
- Fundierte Kenntnisse der Good Clinical Practice (GCP) und relevanter regulatorischer Anforderungen.
- Starke analytische Fähigkeiten und die Fähigkeit, komplexe Daten zu interpretieren.
- Ausgezeichnete Kommunikations- und Präsentationsfähigkeiten in Deutsch und Englisch.
- Hohe Eigeninitiative, Ergebnisorientierung und Organisationsgeschick.
- Fähigkeit, selbstständig und im Team zu arbeiten, auch in einem verteilten Arbeitsumfeld.
- Erfahrung im Umgang mit klinischen Datenmanagement-Systemen.
- Vertrautheit mit modernen Forschungsmethoden und Technologien.
- Bereitschaft zur kontinuierlichen Weiterbildung und Anpassung an sich ändernde regulatorische Rahmenbedingungen.
Leider ist dieser Job in Ihrer Region nicht verfügbar
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Clinical Research Scientist (Remote)
7000 Eisenstadt, Burgenland
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Arbeitsbeschreibung
Werden Sie Teil eines global führenden Pharmaunternehmens und gestalten Sie die Zukunft der medizinischen Forschung mit – bequem von Ihrem Home-Office aus! Unser Kunde sucht einen hochqualifizierten und erfahrenen Clinical Research Scientist (w/m/d) für sein remote-basiertes Team. Wenn Sie eine Leidenschaft für wissenschaftliche Exzellenz haben und einen signifikanten Beitrag zur Entwicklung neuer Therapien leisten möchten, bieten wir Ihnen hier die perfekte Gelegenheit. Diese Rolle ist vollständig auf Remote-Arbeit ausgelegt, was Ihnen maximale Flexibilität ermöglicht, während Sie an wegweisenden klinischen Studien mitarbeiten.
Ihre Aufgaben:
Ihr Profil:
Ihre Aufgaben:
- Konzeption, Planung und Überwachung klinischer Studien gemäß internationalen Richtlinien (ICH-GCP, FDA, EMA).
- Entwicklung von Studienprotokollen, Änderungsanträgen und anderen studienrelevanten Dokumenten.
- Analyse und Interpretation von Studienergebnissen sowie Erstellung von Berichten und Publikationen.
- Zusammenarbeit mit internen Abteilungen (z.B. Medical Affairs, Regulatory Affairs, Data Management) und externen Partnern (z.B. CROs, Prüfärzte).
- Sicherstellung der Datenqualität und -integrität in den klinischen Studien.
- Bewertung von potenziellen Risiken und Erarbeitung von Strategien zu deren Minimierung.
- Teilnahme an Studienvisiten und Meetings mit Prüfzentren.
- Aktive Beteiligung an der Auswahl und Qualifizierung von Prüfzentren und Prüfern.
- Budgetverantwortung für zugewiesene Studienprojekte.
- Präsentation von Studienergebnissen auf wissenschaftlichen Kongressen und internen Meetings.
- Unterstützung bei der Erstellung von Zulassungsdossiers.
- Kontinuierliche Beobachtung wissenschaftlicher Entwicklungen und neuer Therapieansätze.
- Gewährleistung der Einhaltung aller relevanten regulatorischen Anforderungen.
- Mentoring von Junior-Mitarbeitern im Bereich klinische Forschung.
Ihr Profil:
- Promotion (PhD) oder Master-Abschluss in Naturwissenschaften, Medizin, Pharmazie oder einem verwandten Feld.
- Mehrjährige relevante Berufserfahrung in der klinischen Forschung, idealerweise in der Pharmaindustrie oder einer CRO.
- Tiefgreifende Kenntnisse der Prinzipien klinischer Studien, GCP und regulatorischer Anforderungen.
- Erfahrung in der Studienplanung, -durchführung und -auswertung.
- Starke wissenschaftliche und analytische Fähigkeiten sowie die Fähigkeit, komplexe Daten zu interpretieren.
- Ausgezeichnete schriftliche und mündliche Kommunikationsfähigkeiten in Deutsch und Englisch.
- Fähigkeit zur selbstständigen und strukturierten Arbeitsweise im Home-Office.
- Hohe Motivation, Belastbarkeit und Teamfähigkeit auch in einem verteilten Arbeitsumfeld.
- Bereitschaft zu gelegentlichen Reisen für Konferenzen oder wichtige Meetings (maximal 10-15%).
- Vertrautheit mit relevanten Softwaretools (z.B. EDC-Systeme, statistische Software).
Leider ist dieser Job in Ihrer Region nicht verfügbar
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