Data Manager (f/m/d)

Descrizione del lavoro:

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 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.

Qualifications:

* 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)

Additional Information:

Contacts by headhunters, recruiting or staffing agencies are not accepted!
Please send your application including anticipated salary