Data Manager (f/m/d)

Eurofins; Hamburg; Vor Ort; EUR 55.000 - 85.000; Vollzeit

Zusammenfassung

Eurofins bioskin is seeking a Data Manager in clinical trials to join our team in Hamburg. The role includes creating eCRFs, developing and maintaining study databases, and coordinating data entry, cleaning, and query management.

You will implement strategies for clinical research databases in accordance with ICH, GCP, and CDISC standards, and contribute to SOP development and study timelines. English proficiency is required.

Qualifikationen

• 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 nice to have.
• Well versed in English (written and spoken).

Aufgaben

• Familiarization with current scientific developments within the scope of the task area.
• Participation in/organization of meetings with clients/trainings.
• Development and implementation of strategies for introducing clinical research databases (ICH, GCP, CDISC).
• Development of (e)CRF standard modules.
• Creation and revision of data management SOPs and workflows.
• Project management within the scope of DM activities.
• Preparation of study-specific schedules of tasks in coordination with departments.
• Creation and adherence to Data Management Plan and related documents.
• Definition, programming and validation of data checks and transfers.
• Data review, cleaning and query management.
• Third party data handling.
• Coding of diseases, adverse events and drugs (WHO Drug Global or MedDRA).
• Organization and execution of third party and SAE reconciliation.

Kenntnisse

ICH GCP knowledge

Data management

English proficiency

CDISC knowledge (nice to have)

Ausbildung

University degree in natural sciences

Tools

eCRF design tools

SOPs in data management

Jobbeschreibung

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.

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)