Data Manager (f/m/d)

Eurofins; Deutschland; Vor Ort; EUR 55.000 - 75.000; Vollzeit

Zusammenfassung

Eurofins bioskin is looking for a Data Manager in clinical trials to join our team in Germany. You will create eCRFs, develop and maintain study databases, and coordinate data entry, data cleaning, and query management.

Responsibilities also include developing strategies for data management, implementing CDISC/ICH GCP standards, defining edit checks, creating and revising DM SOPs, and coordinating timelines with relevant departments.

Qualifikationen

• University degree in natural sciences or equivalent.
• Working knowledge of ICH GCP guidelines.
• Experience with CDISC standards would be a nice to have.

Aufgaben

• Create and maintain eCRFs and study databases.
• Coordinate data entry, data cleaning and query management.
• Develop and implement data management strategies and SOPs.
• Ensure compliance with CDISC/ICH GCP standards and data transfers.
• Coordinate timelines with relevant departments.

Kenntnisse

English proficiency

Organized

Ausbildung

University degree in natural sciences

Tools

CDISC standards

eCRF systems

Jobbeschreibung

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)