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:
Assistant Clinical Monitoring (f/m/d)
We are looking for an Assistant Clinical Monitoring to join our team at bioskin in Hamburg. As a Clinical Monitor Assistant you will be an integral part of the monitoring team and responsible for coordinating operations within the team and providing administrative support to CRAs based on the sponsor's or bioskin's Standard Operation Procedures (SOPs), Good Clinical Practice (GCP) and regulatory requirements.
Your main responsibilities:
- Preparation or compilation of documents relevant to the trials for monitoring purposes
- Review doucments collected by CRAs for accuracy and completeness as required by the DIA Model or Trial Master File Plan
- Assist in compiling documents for filing in the paper-based TMF or uploading documents to the electronic TMF
- Preparation and mailing of investigator folders
- Feasibility queries for the evaluation of trial sites
- Collaboration in the preparation of presentations, e.g. for initiation visits, internal trainings etc.
- Support of Head Monitoring e.g. in the review of visit accounts
- Dispatch of SOPs/SOP reading lists and follow-up
- Supporting the team during meetings and writing meeting minutes
- Assist in the creation of monitoring plans
The ideal candidate will need the following experience to be considered:
- Basic knowledge of clinical research processes
- Degree in a scientific 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
- Fluency in German and a high level of English language
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.
Clinical Research Associate (CRA) (f/m/d)
We are looking for an experienced Clinical Research Associate (CRA) to join our team at bioskin in Hamburg. The main task of the CRA is to act as a link between sponsor, CRO and trial site as well as to perform control of clinical trials. The focus is on clinical studies conducted in-house at bioskin or in the Northern German region.
Your main responsibilities:
- Perform all kind of the monitoring visits (site selection, initiation, periodic and close-out visits) as well as remote monitoring
- Generation and updating of monitoring plans and site initiation presentation
- Evaluating the quality and integrity of site practices
- 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 freelance CRAs
- Compliance with protocol, GCP/ICH Guidelines
The idal candidate will need the following experience to be considered:
- At least 2 years of clinical monitoring experience (preferred dermatology)
- Degree in a scientific 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
- Fluency in German and a high level of English language
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.
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.
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.
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!
Trial Master File Manager (f/m/d)
We are looking for a Trial Master File Manager to join our team at bioskin in Hamburg. The TMF Manager is responsible for the management of document filing and archival processes in both paper TMF and electronic TMF, ensuring that the documentation can fully reconstruct the conduct of a clinical study.
Focus of tasks:
The TMF Manager will
- perform all aspects of TMF management activities including set-up according to each clinical studies' specifications document management, and archiving.
- plan and perform the quality review and prepare the TMF for audits/inspections.
- participate in Trial Team meetings and provide regular TMF updates.
- oversee the consolidation of outsourced elements of the TMF with third parties e.g., other CROs and vendors.
- ensure adherence to Standard Operating Procedures, Good Clinical Practice, and International Council for Harmonization E6(R2).
Profile:
- Interested in document management with attention to details
- Well-structured and organized with the ability to manage multiple projects and to effectively prioritize tasks
- Good English skills (written and spoken)
- Competent with MS Office applications
Preferred qualification:
- Experience in Trial Master File Management
- Knowledge of the DIA TMF Reference Model
- Knolwedge of eTMF systems
- Basic understanding of clinical trials and familiarity with ICH-GCP guidelines, regulatory requirements, monitoring procedures and clinical study processes
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.