Data Manager (f/m/d)

We are looking for an Data Manager in clinical trials to join our team at 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 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) and
• Development of (e)CRF standard modules and
• 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.

• 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 application including anticipated salary.

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.