You manage data-related tasks in clinical research, ensuring compliance with standards while coordinating schedules, organizing meetings, and overseeing data integrity and coding processes.
Anforderungen
- •University degree in natural sciences
- •Working knowledge of ICH GCP guidelines
- •Experience in data structures development (CDISC standards) is a nice to have
- •Dependable, well-structured, organized, target-oriented personality
- •Team player
- •Well versed in English (written and spoken)
Deine Aufgaben
- •Stay updated on scientific developments in the field.
- •Organize and participate in meetings and training sessions.
- •Develop strategies for clinical research databases.
- •Create and implement (e)CRF standard modules.
- •Revise data management SOPs and workflows.
- •Manage projects related to data management activities.
- •Prepare study-specific schedules in coordination with departments.
- •Create and follow the audit-specific Data Management Plan.
- •Define, program, and validate data checks and transfers.
- •Review data, clean data, and manage queries.
- •Handle third-party and device data.
- •Code diseases, adverse events, and drugs per study systems.
- •Organize and execute third-party and SAE reconciliation.
Original Beschreibung
## 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!**