Clinical Data Specialist
vor 4 Wochen
Location: Berlin
Position: Clinical Data Specialist (m/w/d)
The Fraunhofer Society operates 76 institutes and research facilities across Germany and is the world's leading organization for applied research. With approximately 30,000 employees, it generates an annual research volume of 3.0 billion euros.
The Fraunhofer Institute for Translational Medicine and Pharmacology ITMP-IA in Berlin-Steglitz focuses on developing improved solutions for patients suffering from allergies and other mast cell-mediated diseases. We are seeking a Clinical Data Specialist to manage data for multiple studies at our research center.
- Establishing and overseeing clinical trials in collaboration with relevant departments
- Contributing to the review and development of study protocols
- Creating Case Report Forms (CRFs) based on study protocols through requirements analysis and defining the parameters to be collected along with other technical specifications
- Validating electronic CRFs (eCRFs) by developing and executing test plans
- Drafting and reviewing data management and validation plans, as well as other study documents
- Conducting query processes, data validation, serious adverse event reconciliation, and medical coding
- Planning, programming, validating, and executing listings, reports, and metrics
- Providing guidance to users of Electronic Data Capture (EDC) systems
- Coordinating the entire data flow, including monitoring and managing study data from CRF creation to database closure and documentation preparation
- Validating software within the context of clinical studies, participating in audits, and enhancing standard operating procedures (SOPs)
- Master's degree in bioinformatics, data sciences, life sciences, or a related field with a qualification in clinical research
- At least 3 years of professional experience in clinical study data management in accordance with AMG/ICH-GCP (preferably Phase I/II)
- Experience in creating study-specific data management documents per ICH-GCP with a solid understanding of data management processes, as well as AMG and GCP regulations
- Proficient use of EDC systems (e.g., SecuTrial, Viedoc, Clincase)
- Ideally, knowledge of eCRF setup, familiarity with MedDRA and WHO Drug Dictionary, and clinical data standards (CDISC SDTM, CDASH)
- Experience with handling paper-based source data and patient questionnaires/diaries is a plus
- Excellent command of German and English, both written and spoken; knowledge of programming languages such as SAS, SQL, VBA, and JavaScript is advantageous
- Strong awareness of timely, structured, and traceable documentation practices
- A communicative team player who proactively solves problems and operates independently, methodically, and diligently
- Independent and responsible work environment
- Flexible working hours
- Comprehensive onboarding and ongoing support, including opportunities for further training and additional qualifications
- Opportunities to shape the new Fraunhofer Institute
- Career advancement prospects
- Collaborative work within a motivated team of physicians, scientists, study coordinators, and study assistants
- Diverse and engaging projects
We value and promote the diversity of our employees' skills and welcome all applications, regardless of age, gender, nationality, ethnic and social background, religion, belief, disability, or sexual orientation and identity. Individuals with disabilities will be given preference if equally qualified.
The weekly working hours amount to 39 hours. The position is initially limited and can also be filled part-time. Employment, remuneration, and social benefits are based on the collective agreement for the public service (TVöD).
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