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:
Clinical Research Associate (CRA Level 1) (f/m/d) - Home based - Munich Area
We are looking for an experienced Clinical Research Associate (CRA) to join our team at bioskin. 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:
- 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
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.
Junior Clinical Research Associate (CRA level 1) (f/m/d)
We are looking for a Junior 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:
- 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 1 year 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
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, and being 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 sponsor contact for all regulatory questions/issues
- Primary contact for regulatory authorities and ethics committees and responsible for all related communication
- Counselling of the sponsor for all national regulations and timelines
- Sponsor support for queries and requests by authorities and committees
- Ongoing control and alignment of submission processes to any changes in applicable (local) laws, regulations and directives and management of training accordingly
- Safety reporting
- Set-up and maintenance of submission tracking tools
- 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:
- Degree in a scientific or medical discipline
- 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.