• 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

• Familiarization with current scientific developments within the scope of the task area
• Participation in/organization of meetings and telephone conferences in-house/with clients/training sessions, seminars
• Development and implementation of strategies for the introduction of clinical research databases in accordance with the applicable international standards (ICH, GCP, CDISC)
• Development of (e)CRF standard modules
• Creation and revision of data management SOPs and the workflows described therein
• Project management within the scope of DM activities
• Preparation of a study-specific schedule/schedule (timelines) of tasks related to the function in coordination with the relevant departments
• Creation and adherence to the audit-specific Data Management Plan and related documents
• Definition, programming and validation of completeness and plausibility checks (edit checks) and data transfer.
• Data review, data cleaning and query Management
• Third Party data/Device data handling
• Coding of diseases, adverse events and drugs according to study-specific coding systems, e. g., WHO Drug Global or MedDRA
• Organization and execution of third party and SAE reconciliation

Profile:

• University degree in natural sciences or other comparable degree
• Working knowledge of ICH GCP guidelines
• Experience in development of data structures according to CDISC standards would be a nice to have
• Dependable, well-structured and organized, target-oriented personality, team player
• Well versed in English (written and spoken)

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

Please send your complete application including your anticipated salary to

• Clinical Study Reports (CSRs) according to ICH-E3 for single and multicenter trials
• Preparation of appendices for CSRs
• Linking and bookmarking processes
• CSRs in Common Technical Document (CTD) or electronic Common Technical Document (eCTD) for application dossier
• Research reports for non-drug studies, as well as abbreviated reports
• Study protocols, subject information leaflets
• Scientific publications (journal articles, abstracts, posters)
• Editing and review of documents assuring that documents comply with regulatory, journal, or other guidelines in terms of content, format and structure
• Investigational Medicinal Product Dossier
• Investigator’s Brochure
• Regulatory documentation (IND, briefing packages, etc.)

• 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

• 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

• Set-up and conduct of clinical trials at Eurofins 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