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) (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.
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.
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.
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.