Clinical Data Manager (m/w/d)

Festanstellung

Aschheim

Vollzeit

Vor Ort

60000 - 65000

Pharma & Biotech

Plan, coordinate, and oversee all data-management activities for TRiCares-sponsored clinical studies
Design, set up, and test (UAT) electronic Case Report Forms (eCRFs) as well as edit checks
Manage the full eCRF lifecycle from development to database lock in collaboration with external vendors
Prepare and deliver analysis-ready datasets to the external biostatistician
Develop all required data-management documentation, including Data Management Plans (DMP), Data Validation Plans (DVP), and annotated CRFs
Contribute to the development and writing of clinical study documentation
Ensure complete and accurate documentation and filing in the Trial Master File (TMF)
Analyze and interpret clinical data to identify and address discrepancies to ensure high data quality
Support timely data collection, query management, and data-cleaning activities
Ensure compliance with regulatory standards, quality expectations, and best practices in clinical trial data management
Collaborate closely with cross-functional teams to ensure smooth execution of clinical studies.

University degree in data science, statistics, computer science or comparable studies
At least two years of professional experience as a data manger with responsibility for clinical studies
Knowledge of CDISC standards

Knowledge of applicable guidelines such as ISO-14155 and ICH-GCP as well as relevant clinical terminology
Knowledge of programming languages is a plus
Strong attention to detail, with excellent organizational and teamwork skills
Strong analytical and logical thinking skills
Knowledge of cardiovascular medicine is a plus
Proficiency in English is required; German language skills are an advantage.