Data Manager (f/m/d)

Eurofins Germany

19h•Onsite

About The Position

Eurofins bioskin is seeking a Data Manager to join their clinical trials team. The Data Manager will be responsible for creating Case Report Forms (eCRF/pCRF), developing and maintaining study databases, and coordinating data entry, data cleaning, and query management. This role involves staying familiar with current scientific developments, participating in meetings, developing and implementing strategies for clinical research databases according to international standards (ICH, GCP, CDISC), and developing (e)CRF standard modules. The Data Manager will also create and revise data management SOPs, manage projects within DM activities, prepare study-specific schedules, create and adhere to the Data Management Plan, define and validate edit checks and data transfers, perform data review, cleaning, and query management, handle third-party and device data, and code diseases, adverse events, and drugs. Additionally, the role includes organizing and executing third-party and SAE reconciliation.

Requirements

University degree in natural sciences or other comparable degree
Working knowledge of ICH GCP guidelines
Dependable, well-structured and organized, target-oriented personality, team player
Well versed in English (written and spoken)

Nice To Haves

Experience in development of data structures according to CDISC standards

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)
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.