Clinical Data Manager
Posted on Mar 17, 2019 by AL2S3 LTD
AL Solutions are looking for an experienced Clinical Data Manager to work for a small full service CRO based in Prague. My client are rapidly expanding their data management department and can offer excellent career progression paths for employees. The correct candidate will serve as the primary data management contact with sponsors and represent the department in the different project teams.
Ensure the proper collection, management, and storage of clinical trial data (according to regulatory requirements).
Ensure proper clinical data validation, review and query management.
Maintains current study documentation and which accurately reflect process deviations and changes in project assumptions.
Coordinates receipt and handling of data received from external service providers and directs reconciliation where applicable
Recommends alternative work processes to improve quality or speed of customer deliverables and responds to questions on Data Management process, timelines, and data quality.
Conducts post-mortem analysis after study completion/major milestone to determine positive and negative factors affecting the project and provides information along with study metrics to Head of Data Management.
Basic knowledge of CDISC-SDTM data standardization specifications
Experience with EDC systems, in depth understanding of relational Databases
Experience with use of standardized CRFs libraries
Relevant clinical trial Data Management experience in the pharma/biotech industry
Bachelors degree in medical, scientific, biological, statistical, computer science or related field
Experience in planning, setup, conduct and reporting of different stage clinical trials
AL Solutions are a niche Life Science recruitment consultancy. We place professionals across the UK/EU for a variety of biotechnology, pharmaceutical and CRO companies ranging from small start-ups to large global organisations.
If you're interested, please apply below. If this position doesn't interest you, please visit our website for a list of more vacancies.