Thank you very much for your interest in a position at bioskin.
We currently have openings for the following positions:

Clinical Trial Management Assistant (f/m)
We are looking for a Clinical Trial Management Assistant to join our team at bioskin in Hamburg. The Clinical Trial Management's essential function is to support the organization and management of clinical trials at bioskin, correspond with internal and external Partners and vendors and support the trial team in all administrative tasks in the context of clinical trials. 

Focus of tasks:
  • Support the trial team in all aspects of the organization and management of clincial trials according to ICH-GCP, applicable regulations and SOPs
  • Support the Trial team in generating and updating trial related documents and manuals
  • Provide support in compilation and submission of packages for clinical trial applications to authorities and ethics committees
  • Set up, maintain and review trial master files including supporting quality control of documents
  • Accurately monitor, update and maintain Trial status and overview lists
  • Support the organization and coordication of internal and external meetings
  • Prepare and review meeting minutes

Profile:

  • Scientific Degree, Medical documentation officer certification or equivalent Medical, scientific or pharmaceutical education
  • Experience in the area of clinical trial management or clinical research, ideally multicenter and multinational trial experience
  • Strong organziational and communication skills; team spirit
  • Ability to work in a structured manner, experience in dealing with external parties, good time management
  • Results-oriented approach, flexible and proactive attitude towards changing needs; willingness to work on different projects simultaneously
  • Very good English skills, both written and spoken
  • Knowledge of the current national and international laws and guidelines regarding the conduct of clinical trials

Contacts by headhunters, recruiting or staffing agencies are not accepted!

Please send your application including your anticipated salary to

bioskin GmbH • Burchardstraße 17 • 20095 Hamburg • Germany •
Bettina Möhlenbrock • bewerbung@bioskinCRO.com
Please send applications by e-mail as pdf file.
Clinical Trial Manager (f/m)
We are looking for a Clinical Trial Manager with long-standing experience to join our team at bioskin in Hamburg. The Clinical Trial 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 window person for the sponsor.

Focus of tasks:
  • Planning and coordinating of clinical trials at bioskin
  • Clinical trial setup
  • Generation of essential documents (trial protocols, subject information, regulatory documents)
  • Clinical Trial Application to ethics committees and authorities
  • Management of involved parties
  • TMF maintenance
  • Budget responsibility

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 organziational 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 • Burchardstraße 17 • 20095 Hamburg • Germany •
Bettina Möhlenbrock • bewerbung@bioskinCRO.com
Please send applications by e-mail as pdf file.
Clinical Research Associate (CRA) (f/m)
We are looking for an experienced Clinical Research Associate (CRA) to join our team at bioskin in Hamburg. The CRA's essential function is to act as a link between sponsor, CRO and trial site as well as the quality control of early phase clinical trials in-house at bioskin as well as multicenter trials at the sites in Germany or other German-speaking countries.
 
Focus of tasks:
  • 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
  • Organizing investigator meetings together with the study team
  • 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
  • Feasibility of sites
  • Preselection visits, initiation visits, periodic monitoring and close out visits
  • 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 3-4 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 regulaotry requirements
  • Well-structured and organized, target-oriented personality, team player
  • Ability to thouroughly 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 complete application including your anticipated salary to

bioskin GmbH • Burchardstraße 17 • 20095 Hamburg • Germany
Bettina Möhlenbrock • bewerbung@bioskinCRO.com
Please send applications by e-mail as pdf file.
Dermatologist (f/m)
bioskin is a full-service CRO specialized in dermatology, working in an international environment. We are looking for a dermatologist to join our clinical team in Hamburg in an either part or full time position. 
 
Focus of tasks:
  • Provides medical input during development of clinical trial protocols 
  • Investigator in clinical trials, working according to clinical trial protocol, ICH-GCP and local regulations
  • Attends to patients within the scope of clinical trials
  • Performs physical exams, dermatological evaluation of skin disease severity, scoring of skin tolerability, sonographical and biophysical measurements 
  • Evaluates lab and ECG reports
  • Assesses any adverse events of investigative medicinal products
  • Participates in study initiation and monitoring visits as well as sponsor audit visits 
  • Contact for clinical team and sponsor regarding medical issues
  • Performs medical monitoring over subject safety data

Profile:

  • Licensed physician and board certified dermatologist
  • Experience in conducting clinical research
  • Knowledge of ICH-GCP as well as applicable local regulations (AMG, MPG)
  • Versed in MS Office
  • Dependable, thorough, well-structured and organized, team player
  • Fluent German and very good English skills (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 • Burchardstraße 17 • 20095 Hamburg • Germany
Bettina Möhlenbrock • bewerbung@bioskinCRO.com
Please send applications by e-mail as pdf file.
Study Nurse (w/m)

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)

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
  • Möglichst Vorerfahrung 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:

bioskin GmbH • Burchardstraße 17 • 20095 Hamburg
Bettina Möhlenbrock • bewerbung@bioskinCRO.com
 
Wir bitten, E-Mail Bewerbungen als PDF-Datei zu schicken.

Angebote und Kontakte von Headhuntern, Rekrutierungsagenturen und Personalvermittlern werden nicht akzeptiert!

Unsolicited applications

If there are no current vacancies or your position is not listed, you are always welcome to send us an unsolicited application to: 

bioskin® GmbH
Burchardstrasse 17 · 20095 Hamburg, Germany
Phone: +49-40-606897-0 · Fax: +49-40-606897-30

bewerbung@bioskinCRO.com