Clinical Data Manager (f/m/d - part/full-time)

Staburo GmbH; München; Hybrid; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

A data management company in Munich seeks an experienced Data Manager to oversee clinical studies. Responsibilities include CRF design, database setup, and user acceptance testing. Ideal candidates have a degree in data science or related fields, 2+ years of experience, and knowledge of CDISC standards. The role offers flexible working hours, development opportunities, and a harmonious work environment.

Leistungen

Individual development opportunities

Continuous training

Subsidized canteen

Flexible working hours

Modern office

Remote work options

Qualifikationen

• At least two years of professional experience as a data manager with responsibility for clinical studies.
• Knowledge of CDISC standards (CDASH, SDTM, define.xml, cSDRG).
• Knowledge of relevant guidelines GCP, ICH.

Aufgaben

• CRF design and database design.
• Creation of Data Management Plan and Data Validation Plan.
• User acceptance testing including creating testing scenarios.

Kenntnisse

Data management

Understanding of SOPs

Analytical thinking

Team player

Good English skills

Quick comprehension

Ausbildung

University degree in data science, statistics, computer science

Jobbeschreibung

Your responsibilities will include

• CRF design
• Database design and set-up
• Creation of Data Management Plan and Data Validation Plan
• User acceptance testing (including creating testing scenarios)
• eCRF completion guideline
• Data cleaning, SAE reconciliation, query management
• Medical coding (e.g., MedDRA,WHO-DD)
• Programming of plausibility checks
• User Access Management
• Creation of SDTMs, define.xml and cSDRG is an advantage

Your profile

• University degree in data science, statistics, computer science, or comparable studies
• At least two years of professional experience as a data manager with responsibility for clinical studies
• Ability to understand and follow SOPs, working instructions and relevant guidelines
• Knowledge of CDISC standards (CDASH, SDTM, define.xml, cSDRG)
• Knowledge of relevant terminology in clinical and non-clinical research
• Knowledge of relevant guidelines GCP, ICH
• Quick comprehension and analytical thinking
• Team player with high degree of initiative
• Good English skills, German is an advantage

What we offer you

We value communication, flat hierarchies, open corporate culture, and a harmonious work environment. We offer comprehensive individual development opportunities, continuous trainings, and flexible working hours. A modern and bright office with a subsidised canteen, as well as the opportunity to work 2 days per week from home are part of our everyday working life. Full remote work from anywhere in Germany for those who do not live in Munich can be discussed. You will join an interdisciplinary team allowing you to discuss with and learn from peers with many different backgrounds.

Question?

If you have any questions, please feel free to contact us by e-mail [e-mail].