Data Manager (f/m/d)

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

Zusammenfassung

Eurofins bioskin is seeking a Data Manager in clinical trials to join the team. The Data Manager will create eCRF/pCRF, develop and maintain study databases, and coordinate data entry, cleaning, and query management.

Responsibilities include developing DM strategies aligned with ICH, GCP, and CDISC, creating CRF modules, and maintaining DM SOPs and workflows. English proficiency is required for this role.

Qualifikationen

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

Aufgaben

• 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 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.

Ausbildung

University degree in natural sciences

Jobbeschreibung

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)