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, repsect 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 - Muenster, Bonn, Stuttgart or Karlsruhe
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.
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.