Company Description

Eurofins bioskin is a leading niche CRO with unique understanding and capabilities for both early and late phase development of dermatological and related products. Since its inception in 1992, bioskin has been recognized as a valuable partner for dermatological product development. Starting as a small Contract Research Organization (CRO) specialized in conducting early phase safety and efficacy trials, bioskin has grown into a full-service CRO offering global dermatologic consulting and regulatory services and all services for management of Phase I-IV drug trials and claim support/safety studies. bioskin is headquartered in Hamburg, Germany.

Job Description

We are looking for an Data Manager in clinical trials to join our team at Eurofins bioskin. The Data Manager is responsible for creating Case Report Forms (eCRF/pCRF), developing and maintaining study databases, and coordinating data entry, data cleaning, and query management.

Your main responsibilities: 

Familiarization with current scientific developments within the scope of the task areaParticipation in/organization of meetings and telephone conferences in-house / with clients / training sessions, seminarsDevelopment and implementation of strategies for the introduction of clinical research databases in accordance with the applicable international standards (ICH, GCP, CDISC) andDevelopment of (e)CRF standard modules andCreation and revision of data management SOPs and the workflows described thereinProject management within the scope of DM activitiesPreparation of a study-specific schedule/schedule (timelines) of tasks related to the function in coordination with the relevant departmentsCreation and adherence to the audit-specific Data Management Plan and related documentsDefinition, programming and validation of completeness and plausibility checks (edit checks) and data transfer.Data review, data cleaning and query ManagementThird Party data / Device data handlingCoding 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.

QualificationsUniversity degree in natural sciences or other comparable degreeWorking knowledge of ICH GCP guidelinesExperience in development of data structures according to CDISC standards would be a nice to haveDependable, well-structured and organized, target-oriented personality, team playerWell versed in English (written and spoken)

Additional Information

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

Please send your application including anticipated salary.