Job
- Level
- Experienced
- Location
- Hamburg
- Working Model
- Onsite
- Job Field
- Database
- Employment Type
- Full Time
- Contract Type
- Permanent employment
Job Summary
In this role, you will develop eCRFs and study databases, coordinate data entry and cleaning, and manage queries while implementing international standards such as ICH GCP.
Your role in the team
- We are looking for a 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.
- Erstellung und Überarbeitung von SOPs für das Datenmanagement und die darin beschriebenen Workflows.
- Projektmanagement im Rahmen der DM-Aktivitäten.
- Preparation of a study-specific schedule/schedule (timelines) of tasks related to the function in coordination with the relevant departments.
- Erstellung und Einhaltung des auditspezifischen Data Management Plans und der zugehörigen Dokumente.
- 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.
This text has been machine translated. Show original
Our expectations of you
Education
- University degree in natural sciences or other comparable degree.
Qualifications
- Working knowledge of ICH GCP guidelines.
- Dependable, well-structured and organized, target-oriented personality, team player.
- Well versed in English (written and spoken).
Experience
- Experience in development of data structures according to CDISC standards would be a nice to have.
This text has been machine translated. Show original
What we offer
- Contacts by headhunters, recruiting or staffing agencies are not accepted!
- Please send your application including anticipated salary.
This text has been machine translated. Show original
Benefits
Health, Fitness & Fun
Food & Drink
Higher Take-Home Pay
Work-Life-Integration
Job Locations
About Your Employer
Eurofins Scientific
As a leading provider of analytical services for food, environmental, pharmaceutical, and cosmetic products, Eurofins is dedicated to providing innovative solutions for its customers across various industries. In addition, Eurofins also offers agricultural contract research services (CRO). With its wide range of offerings and expertise, Eurofins is your one-stop shop for all your analytical needs.
Description
- Company Size
- 50-249 Employees
- Company Type
- Established Company
- Working Model
- Hybrid, Onsite
- Industry
- Pharmaceutical Sector, Chemical Industry, Biotech, Science, Research
Data Manager
- Location
- Hamburg
- Working Model
- Onsite
- Diversity
- Open for all genders
- English Only
- English only required
