Job
- Level
- Erfahren
- Ort
- Hamburg
- Arbeitsmodell
- Onsite
- Job Feld
- Database
- Anstellung
- Vollzeit
- Vertragsart
- Unbefristetes Dienstverhältnis
Job Zusammenfassung
In diesem Job entwickelst du eCRFs und Studien-Datenbanken, koordinierst die Dateneingabe und -reinigung sowie das Management von Anfragen, während du internationale Standards wie ICH GCP umsetzt.
Deine Rolle im Team
- 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.
- 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).
- Development of (e)CRF standard modules.
- 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.
Unsere Erwartungen an dich
Ausbildung
- University degree in natural sciences or other comparable degree.
Qualifikationen
- Working knowledge of ICH GCP guidelines.
- Dependable, well-structured and organized, target-oriented personality, team player.
- Well versed in English (written and spoken).
Erfahrung
- Experience in development of data structures according to CDISC standards would be a nice to have.
Unser Angebot
- Contacts by headhunters, recruiting or staffing agencies are not accepted!
- Please send your application including anticipated salary.
Benefits
Gesundheit, Fitness & Fun
Essen & Trinken
Mehr Netto
Work-Life-Integration
Job Standorte
Das ist dein Arbeitgeber
Eurofins Scientific
Eurofins bietet seinen weltweiten Kunden aus verschiedensten Branchen einzigartige Analyse-Dienstleistungen an. Das Unternehmen ist spezialisiert auf Lebensmittel-, Umwelt-, pharmazeutische und kosmetische Produkte sowie agrarwissenschaftliche Forschungs-Dienstleistungen (CRO) und gilt als Marktführer.
Description
- Unternehmensgröße
- 50-249 Employees
- Unternehmenstyp
- Etablierte Firma
- Arbeitsmodell
- Hybrid, Onsite
- Branche
- Pharma, Chemie, Biotech, Wissenschaft, Forschung
Data Manager
- Ort
- Hamburg
- Arbeitsmodell
- Onsite
- Diversität
- Für alle Personen geeignet (m/w/d)
- Nur Englisch
- Nur Englisch erforderlich
