Offer summary

Qualifications:

University degree in natural sciences or a related field., Working knowledge of ICH GCP guidelines., Experience with data management in clinical trials is preferred., Proficiency in English, both written and spoken..

Key responsibilities:

Create and maintain study databases and (e)CRF modules.

Coordinate data entry, cleaning, and query management during clinical trials.

Develop strategies for implementing clinical research databases according to international standards.

Participate in meetings, develop SOPs, and manage project timelines and documentation.

Job description

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)