Your career at bioskin
Join the Eurofins bioskin team!
We believe that our employees are our most valuable resource!
Eurofins 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.
Eurofins bioskin offers a working environment that is based on trust, respect and common values.
As member of the Eurofins 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
- Company pension plan plus company supplement
- HVV Profiticket with company supplement
Would you like to work in the middle of the Hamburg Altstadt in the direct neighbourhood of the world cultural heritage Chilehaus, and in within eyeshot of the Speicherstadt and Hafencity/Elbphilharmony in walking distance? Here, right next to the "Messberg" subway station or even just a 10-minute walk to the main train station "Hauptbahnhof" you can find lots of places for a perfect lunch break in many different restaurants. Our modern offices, designed for 2-4 people, are in the Danske Hus, which of course has a bicycle cellar in the underground garage for employees who want to come to work by bike.
It's a perfect working environment in a great team in the most beautiful area of the most beautiful city!
If there are no current vacancies or your position is not listed below, you are always welcome to send us an unsolicited application to:
Eurofins bioskin
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:
- 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.
We are looking for a Data Manager (f/m/d) in clinical trials to join our team at bioskin in Hamburg. The Data Manager is responsible for creating Case Report Forms (eCRF/pCRF), developing and maintaining study databases, and coordinating data entry, data cleaning, and query management.
- Familiarization with current scientific developments within the scope of the task area
- Participation in/organization of meetings and telephone conferences in-house/with clients/training sessions, seminars
- Development and implementation of strategies for the introduction of clinical research databases in accordance with the applicable international standards (ICH, GCP, CDISC)
- Development of (e)CRF standard modules
- Creation and revision of data management SOPs and the workflows described therein
- Project management within the scope of DM activities
- Preparation of a study-specific schedule/schedule (timelines) of tasks related to the function in coordination with the relevant departments
- Creation and adherence to the audit-specific Data Management Plan and related documents
- Definition, programming and validation of completeness and plausibility checks (edit checks) and data transfer.
- Data review, data cleaning and query Management
- Third Party data/Device data handling
- Coding of diseases, adverse events and drugs according to study-specific coding systems, e. g., WHO Drug Global or MedDRA
- Organization and execution of third party and SAE reconciliation
Profile:
- University degree in natural sciences or other comparable degree
- Working knowledge of ICH GCP guidelines
- Experience in development of data structures according to CDISC standards would be a nice to have
- Dependable, well-structured and organized, target-oriented personality, team player
- Well versed in English (written and spoken)
Contacts by headhunters, recruiting or staffing agencies are not accepted!
Please send your complete 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!
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Ongoing review of laboratory and ECG alerts
-
Medical expertise and guidance for project team and clinical sites regarding subject/patient eligibility and safety issues and any protocol-related medical questions during study conduct
-
Safety review of AEs/SAEs
- Review of medical data listings including vital signs, concomitant medication, medical history, laboratory data, amongst other data
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Medical assessment of protocol deviations
- Participates in project team meetings and medical team meetings and serves as medical interface between sponsors and clinical site teams
Qualifications and skills:
- MD licensed in Germany, preferably with specialization in dermatology
- Basic knowledge of clinical research and ICH-GCP required, previous experience in medical monitoring is an additional asset
- Very good English and German (both written and spoken)
- Proactive working style, strong teamworking and communication skills
- Analytical skills and close attention for detail
- Working time 20 – 30 hours per week
Contacts by headhunters, recruiting or staffing agencies are not accepted!
Please send your complete 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.
- Preparation, management and conduct of clinical trial application to regulatory authorities and ethics committees including generation of submission documents within applicable (local) laws, regulations and directives and bioskin quality standards
- Preparation management and conduct of all subsequent submissions
- Primary contact for sponsor, regulatory authorities and ethics committees and responsible for all related communication and regulatory questions/issues
- Counselling of the sponsor for all national regulations and timelines
- Safety reporting
- Overview of submission timelines and budget
- Interface support for bioskin departments e.g. protocol/ICF development, TMF maintenance, risk management
- Results posting in clinical databases
Profile:
- Scientific or medical background with completed apprenticeship and/or degree
- At least 3 years of experience in the area of clinical trial management ideally including regulatory submission or clinical research, multicenter and multinational trial experience is an asset
- Strong organizational and communication skills
- Well-structured and organized, target-oriented personality, team player
- Very good English skills
- Candidates fulfilling the above profile and with additional 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.
- Set-up and conduct of clinical trials at Eurofins 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
- Support (Junior) Project Managers
Profile:
- Degree in a scientific or medical discipline
- At least 5 years of experience in clinical trial management of all study phases (start-up/conduct/closure), thereof at least 3 years project management of multinational trials
- 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.
- Planning, coordination, development and quality control of statistical analyses
- Development of statistical sections of trial protocols
- Conduct of sample size determinations/power analyses
- Generation trial randomizations
- Development of statistical analysis plans (SAP)
- Programming of statistical analyses (tables, listings, figures) according to SAP
- Programming of analysis data sets according to the CDISC ADaM standard
- Validation of SAS programs
- Develop and assist in maintenance of department tools, templates, guidelines, SOPs, and systems
Profile:
- University degree in statistics/mathematics or other comparable degree
- At least 2 years of experience as statistician and/or statistical programmer within the pharmaceutical industry/CRO
- Working knowledge of ICH GCP guidelines
- Experience in development of data structures according to CDISC standards (STDM, ADaM)
- Dependable, well-structured and organized, target-oriented personality, team player
- Well versed in English (written and spoken)
Contacts by headhunters, recruiting or staffing agencies are not accepted!
Please send your complete application including your anticipated salary to
Please send applications by e-mail as pdf file.
Eurofins 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 als PDF-Datei mit Gehaltsvorstellung an:
Angebote und Kontakte von Headhuntern, Rekrutierungsagenturen und Personalvermittlern werden nicht akzeptiert!