• Planning and coordinating of clinical trials at bioskin
• Clinical trial setup
• Generation of essential documents (trial protocols, subject information, regulatory documents)
• Clinical Trial Application to ethics committees and authorities
• Management of involved parties
• TMF maintenance
• Budget responsibility

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

• Performing and reporting site monitoring visits, including site selection, initiation, periodic and close out visits for clinical trials phase I-IV
• Ensuring adherence to international standards (e.g. ICH-GCP), standard operating procedures and clinical trial protocol
• Organizing investigator meetings together with the study team
• Maintaining investigator site files
• Assessing on-going training requirements of all sites staff and take appropriate action
• Identifying and escalating protocol deviations, discrepancies in data, and non-compliance to clinical trial protocols
• Working with different types of eCRF, CTMS systems
• Feasibility of sites
• Preselection visits, initiation visits, periodic monitoring and close out visits
• Collection of essential documents, review and maintenance
• Close cooperation with the different departments in-house at bioskin as well as vendors/freelance CRAs

Profile:

• Degree in a scientific or medical discipline or equivalent
• At least 3-5 years of experience as a Clinical Research Associate are imperative, ideally including multicenter and multinational trials
• Familiar with ICH-GCP guidelines, regulatory requirements, monitoring procedures and understanding of the clinical trial processes
• Experienced in medical device clinical trials and the applicable regulatory requirements
• Well-structured and organized, target-oriented personality, team player
• Ability to thoroughly solve problems and issues
• Fluent in German and English (written and spoken)
• Ability and motivated to travel, including overnight stays
• Competent with MS Office applications
• Candidates with experiences in the indication dermatology will be preferred

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

Please send your application including your anticipated salary to

bioskin is a full-service CRO specialized in dermatology, working in an international environment. We are looking for a dermatologist to join our clinical team in Hamburg in an either part or full time position. 

 

• Provides medical input during development of clinical trial protocols 
• Investigator in clinical trials, working according to clinical trial protocol, ICH-GCP and local regulations
• Attends to patients within the scope of clinical trials
• Performs physical exams, dermatological evaluation of skin disease severity, scoring of skin tolerability, sonographical and biophysical measurements 
• Evaluates lab and ECG reports
• Assesses any adverse events of investigative medicinal products
• Participates in study initiation and monitoring visits as well as sponsor audit visits 
• Contact for clinical team and sponsor regarding medical issues
• Performs medical monitoring over subject safety data

bioskin is a full-service CRO specialized in dermatology, working in an international environment. We are looking for an experienced Medical Writer to join our team at bioskin in Hamburg as soon as possible. The Medical Writer's essential function is to generate clear, comprehensive, carefully focused and precise documents at bioskin in cooperation with all involved departments. Documents are to be standards-compliant, quickly and easily read and understood by scientific, medical and regulatory professionals. 

 

• 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