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:
Data Manager (f/m/d)
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.
Focus of tasks:
- 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
bioskin GmbH • Messberg 4 • 20095 Hamburg • Germany
Bettina Möhlenbrock • bewerbung@bioskinCRO.com
Please send applications by e-mail as pdf file.
Please send applications by e-mail as pdf file.
Empfangsmitarbeiter (w/m/d)
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:
bioskin GmbH • Meßberg 4 • 20095 Hamburg
Bettina Möhlenbrock • bewerbung@bioskinCRO.com
Angebote und Kontakte von Headhuntern, Rekrutierungsagenturen und Personalvermittlern werden nicht akzeptiert!
Junior Project Manager (f/m/d)
We are looking for a Junior Project Manager with basic experience in the field of clinical research to join our team at bioskin in Hamburg. The Junior Project Manager’s essential function is to support Project Managers in clinical studies and to take over clearly defined work packages independently. Furthermore, the Junior Project Manager can be responsible for the management of small clinical studies i.e., coordinating all involved dpartments at bioskin as well as external vendors, and being the primary contact person for the sponsor.
Focus of tasks to assist Project Managers or manage for small studies:
- Set-up and conduct of clinical studies 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, e.g. 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 2 years of experience in the area of clinical study management or clinical research
- 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
bioskin GmbH • Messberg 4 • 20095 Hamburg • Germany
Bettina Möhlenbrock • bewerbung@bioskinCRO.com
Please send applications by e-mail as pdf file.
Please send applications by e-mail as pdf file.
Project Manager (f/m/d)
We are looking for a Project Manager with comprehensive experience to join our team at bioskin in Hamburg. The Project Manager’s essential function is to organize and manage clinical studies at bioskin, coordinating all involved departments at bioskin as well as external vendors, and being the primary contact person for the sponsor.
Focus of tasks:
- 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
bioskin GmbH • Messberg 4 • 20095 Hamburg • Germany •
Bettina Möhlenbrock • bewerbung@bioskinCRO.com
Please send applications by e-mail as pdf file.
Please send applications by e-mail as pdf file.
Regulatory Submission Manager (f/m/d)
We are looking for a Regulatory Submission Manager with comprehensive experience to join our team at bioskin in Hamburg. The Regulatory Submission Manager’s essential function is to organize and manage clinical trial applications for medicinal products, medical devices and cosmetics to regulatory authorities and ethics committees in Germany and EU countries, align with all involved departments at bioskin as well as the sponsor. (S)He is the primary contact person for the authorities, ethics committees as well as the sponsor for all regulatory issues.
Focus of tasks:
- 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
bioskin GmbH • Messberg 4 • 20095 Hamburg • Germany •
Bettina Möhlenbrock • bewerbung@bioskinCRO.com
Please send applications by e-mail as pdf file.
Please send applications by e-mail as pdf file.
SAS programmer (f/m/d)
We are looking for a SAS programmer to join our team in Hamburg.
Your main responsibilities:
- Programming of statistical analyses (tables, listings, figures) according to statistical analysis plans
- Programming of analysis data sets following the CDISC ADaM standard
- Validation of SAS programs including documentation
- Coordination of programming tasks within the team
- Develop and assist in maintenance of department tools, templates, guidelines, SOPs, and systems
Profile:
- University degree in natural sciences or other comparable degree
- At least 2 years of experience as 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
bioskin GmbH • Meßberg 4 • 20095 Hamburg • Germany
Bettina Möhlenbrock • bewerbung@bioskinCRO.com
Please send applications by e-mail as pdf file.
Please send applications by e-mail as pdf file.
Senior Project Manager (f/m/d)
We are looking for a Senior Project Manager with extensive experience to join our team at bioskin in Hamburg. The Senior Project Manager’s essential function is to organize and manage clinical studies at bioskin, coordinating all involved departments at bioskin as well as external vendors, and being the primary contact person for the sponsor. The Senior Project Manager is proactively and independently managing all different project types including complex study designs in a multinational environment.
Focus of tasks:
- 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
- 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
bioskin GmbH • Messberg 4 • 20095 Hamburg • Germany
Bettina Möhlenbrock • bewerbung@bioskinCRO.com
Please send applications by e-mail as pdf file.
Please send applications by e-mail as pdf file.
Statistician (f/m/d)
We are looking for a Statistician in clinical trials to join our team in Hamburg.
Your main responsibilities:
- 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
bioskin GmbH • Meßberg 4 • 20095 Hamburg • Germany
Bettina Möhlenbrock • bewerbung@bioskinCRO.com
Please send applications by e-mail as pdf file.
Please send applications by e-mail as pdf file.
Study Nurse (w/m/d)
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:
bioskin GmbH • Meßberg 4 • 20095 Hamburg
Bettina Möhlenbrock • bewerbung@bioskinCRO.com
Angebote und Kontakte von Headhuntern, Rekrutierungsagenturen und Personalvermittlern werden nicht akzeptiert!