Your career at bioskin
Join the bioskin team!
We believe that our employees are our most valuable resource. bioskin offers the opportunity to personally grow, to increase individual expertise and to broaden experience. We are committed to providing our team with the tools, resources and encouragement to reach professional goals.
bioskin offers a working environment that is based on trust, respect and common values.
As member of the bioskin team you benefit from:
- Training plans for an excellent start
- Flexible working hours with models that range from flex-time and part-time to home office opportunities finding an optimal balance between the needs of the employees and the requirements of the company
- Continuing education and training
- Employer-funded occupational pension system
If there are no current vacancies or your position is not listed below, you are always welcome to send us an unsolicited application to:
bioskin GmbH
Messberg 4 · 20095 Hamburg, Germany
Phone: +49-40-606897-0 · Fax: +49-40-606897-30
bewerbung@bioskinCRO.com
We currently have openings for the following positions:
- Performing and reporting site monitoring visits, including site selection, initiation, periodic and close out visits for clinical trials phase I-IV
- Ensuring adherence to international standards (e.g. ICH-GCP), standard operating procedures and clinical trial protocol
- Acting as Lead CRA
- Performing on-site monitoring, remote monitoring and risk-based monitoring
- Maintaining investigator site files
- Assessing on-going training requirements of all sites staff and take appropriate action
- Identifying and escalating protocol deviations, discrepancies in data, and non-compliance to clinical trial protocols
- Working with different types of eCRF, CTMS systems
- Collection of essential documents, review and maintenance
- Close cooperation with the different departments in-house at bioskin as well as vendors/freelance CRAs
Profile:
- Degree in a scientific or medical discipline or equivalent
- At least 3-5 years of experience as a Clinical Research Associate are imperative, ideally including multicenter and multinational trials
- Familiar with ICH-GCP guidelines, regulatory requirements, monitoring procedures and understanding of the clinical trial processes
- Experienced in medical device clinical trials and the applicable regulatory requirements
- Well-structured and organized, target-oriented personality, team player
- Ability to thoroughly solve problems and issues
- Fluent in German and English (written and spoken)
- Ability and motivated to travel, including overnight stays
- Competent with MS Office applications
- Candidates with experiences in the indication dermatology will be preferred
Contacts by headhunters, recruiting or staffing agencies are not accepted!
Please send your application including your anticipated salary to
Please send applications by e-mail as pdf file.
- Perform all kind of monitoring visits, to include monitoring of proper informed consent procedures, compliance with protocol, GCP/ICH Guidelines
- Working with different types of eCRF, CTMS systems
- Present study materials at investigator/study launch meetings when required
- Evaluating the quality and integrity of site practices – escalating quality issues as appropriate
- Act as contact for clinical trial suppliers and other vendors as assigned
- Identifying and escalating protocol deviations, discrepancies in data, and non-compliance to clinical trial protocols
- Close cooperation with the different departments in-house at bioskin as well as vendors/freelance CRAs
Profile:
- At least 2 years of clinical monitoring experience (preferred dermatology)
- Bachelor’s degree in Life Science or medical discipline or equivalent
- Very good knowledge of Good Clinical Practice/ICH Guidelines
- Proven ability to work independently in a fast-paced environment
- Excellent communication, interpersonal, and organizational skills
- Ability to prioritize
- Strong computer skills
- Fluency in German and a high level of English language
- Flexibility to travel up to 60 % of the working time; depending on model travelling volume can be less and remote monitoring might be included
Contacts by headhunters, recruiting or staffing agencies are not accepted!
Please send your application including your anticipated salary to
Please send applications by e-mail as pdf file.
bioskin GmbH wurde 1992 als dermatologische CRO gegründet und ist mit ca. 65 Mitarbeitern für die GCP-gerechte Auftragsforschung am Standort Hamburg etabliert. bioskin betreut dermatologische klinische Prüfungen der Phasen I-IV im Rahmen von nationalen und internationalen Arzneimittelzulassungen und klinische Prüfungen von Medizinprodukten. Die Studien werden sowohl als in-Haus-Studien bei bioskin als auch multizentrisch innerhalb Deutschlands oder auch international durchgeführt.
Zur Verstärkung unseres Teams suchen wir ab sofort einen
Empfangsmitarbeiter (w/m/d) in Vollzeit
Ihre Aufgaben:
- Eigenverantwortliche Organisation und Management des Empfangssekretariats
- Bedienung der Telefonzentrale mit Annahme, Weiterleitung oder Bearbeitung der eingehenden Anrufe
- Bearbeiten der E-Mail-Eingänge unserer info@-Adresse
- Sichtung und Verteilung der Eingangspost
- Professioneller Empfang und Betreuung von Kunden und Besuchern
- Terminkoordination und Schriftverkehr selbstständig und nach Anweisung
- Organisation und Abwicklung von Dienstreisen
- Überwachung und Beschaffung von Verbrauchsmaterialien
- Versand von Studienmaterialien an die Durchführungszentren
- Administrative Tätigkeiten
Ihr Profil:
- Abgeschlossene kaufmännische Ausbildung oder langjährige kaufmännische Berufserfahrung
- Hohes Maß an Flexibilität, Belastbarkeit, Initiative und Teamfähigkeit
- Kommunikationsstärke und guter Korrespondenzstil
- Durchsetzungsvermögen, verbindliches und freundliches Auftreten
- Sicherer Umgang mit den gängigen MS-Office-Anwendungen
- Diskretion, Loyalität und Zuverlässigkeit
- Sehr gute Deutsch- und Englischkenntnisse in Wort und Schrift
Bitte senden Sie Ihre vollständige Bewerbung mit Gehaltsvorstellung an:
Angebote und Kontakte von Headhuntern, Rekrutierungsagenturen und Personalvermittlern werden nicht akzeptiert!
- Coordinate team and assignments of resources across projects to ensure all targets and deadlines are met
- Co-Monitoring and training of CRA team (in-house and freelance CRAs)
- Identify possible improvements to current processes, determine new processes that are needed, and initiate a plan to improve or develop said processes
- Act as CRA/Lead CRA for a defined project including generation/review of monitoring reports
- Performing on-site monitoring (including site-selection, initiation, periodic and close-out visits) as well as remote monitoring and risk-based monitoring for clinical trials phase I-IV
- Close cooperation with the different departments in-house at bioskin as well as with sponsors/sites/vendors
- Participate in recruitment and selection of CRAs
- Provide strategy and pricing estimates for proposals
- Represent bioskin in bid defenses and investigator meetings
Profile:
- Degree in a scientific or medical discipline
- 10 years of industry experience working on clinical trials and at least 5 years of experience as CRA in leading position are imperative, ideally including multicenter and multinational trials
- Capability to communicate complex issues clearly an credibly
- Ability to solve problems and issues
- Ability and motivated to travel, including overnight stays
- Advanced knowledge of, and ability to, apply GCP/ICH and all applicable regulatory guidelines
- Fluent in German and English (written and spoken)
- Well-structured and organized, target-oriented personality, must work both independently and in a team environment
- Candidates with experiences in the indication dermatology will be preferred
Contacts by headhunters, recruiting or staffing agencies are not accepted!
Please send your application including your anticipated salary to
Please send applications by e-mail as pdf file.
- Set-up and conduct of clinical trials at bioskin within applicable (local) laws, regulations and directives keeping scope, time, budget and quality within scope
- Primary sponsor contact
- Management and oversight of further involved parties including leading of national and international project teams, vendor management
- Set-up and maintenance of timelines and tracking tools
- Set-up and maintenance of trial specific plans and manuals
- Set-up and maintenance of risk management
- Interface support for e.g. protocol/ICF development, feasibility/site selection, EC/regulatory submission, TMF maintenance, clinical monitoring
- Oversight on study budget
Profile:
- Degree in a scientific or medical discipline
- At least 3 years of experience in the area of clinical trial management or clinical research, ideally multicenter and multinational trial experience
- Strong organizational and communication skills
- Well-structured and organized, target-oriented personality, team player
- Very good English skills
- Candidates with experiences in dermatology will be preferred
Contacts by headhunters, recruiting or staffing agencies are not accepted!
Please send your application including your anticipated salary to
Please send applications by e-mail as pdf file.
bioskin ist eine international tätige CRO, spezialisiert auf dermatologische klinische Prüfungen von Arzneimitteln, Medizinprodukten und Kosmetika.
Zur Verstärkung unseres klinischen Teams suchen wir ab sofort eine/n engagierte/n
Study Nurse (w/m/d)
Ihre Aufgaben:
- GCP-konforme Mitarbeit an klinischen Studien
- Assistenz der Prüfärzte
- Durchführung studienspezifischer Aufgaben im nicht-ärztlichen Bereich (Vitalzeichen, Blutentnahmen, Applikation von Prüfmedikation, Anwendung apparativer Messmethoden u.v.m.)
- Erhebung und Dokumentation klinischer Daten in der Probandenakte und CRF/eCRF
- Verwaltung von Studiendokumenten und Prüfmedikation
- Vorbereitung und Assistenz bei Monitor- und Auditbesuchen
Ihr Profil:
- Abgeschlossene Ausbildung in einem medizinischen Assistenzberuf
- Zusatzqualifikation als Study Nurse wäre wünschenswert
- Möglichst Erfahrung in der Durchführung klinischer Studien und auf dem Gebiet der Dermatologie
- Gute Englischkenntnisse in Wort und Schrift
- Sehr gute Kommunikations- und Teamfähigkeit
- Sinn für strukturiertes Arbeiten und Organisationstalent
Bitte senden Sie Ihre vollständige Bewerbung mit Gehaltsvorstellung an:
Angebote und Kontakte von Headhuntern, Rekrutierungsagenturen und Personalvermittlern werden nicht akzeptiert!