15 ago - Mantova
LB Research srl - Clinical Trials Management (Part of 1MED)
LB Research is a Contract Research Organization (CRO) founded in 2007, providing comprehensive clinical research services to both local and multinational pharmaceutical companies. We support the management of a wide range of clinical studies, including interventional and observational trials, as well as studies involving medical devices and food supplements. Our team works closely with Sponsors throughout the entire project lifecycle, from study start-up and contract finalization to database lock, statistical analysis, and final results delivery.
Clinical Data Manager
Job Overview
We are looking for a Clinical Data Manager with 1-3 years of experience to join our Data Management Unit. The Clinical Data Manager will be involved in all phases of the Data Management process, ensuring the accuracy, consistency, and integrity of clinical trial data. The role includes oversight of database design, data entry, data cleaning activities, and database lock procedures, while collaborating closely with Project Managers, Statisticians, and Sponsors.
Key Responsibilities
The Clinical Data Manager will be responsible for:
Database and eCRF Design:
- Defining the database structure and layout for paper CRFs and electronic CRFs (eCRFs).
- Reviewing and verifying CRF/eCRF layouts.
- Defining and implementing eCRF and database validation checks, where applicable.
- Creating and maintaining annotated CRFs.
Data Management Planning:
- Preparing and updating the Data Management Plan (DMP) in collaboration with the Study Project Manager.
- Preparing and maintaining the Edit Check Plan for both paper CRF and eCRF studies.
Data Processing and Quality Control:
- Supervising data entry activities and ensuring the accuracy of data entered into the database.
- Performing or overseeing database reconciliation activities, including double data entry reconciliation when applicable.
- Performing or supervising data cleaning activities according to the Edit Check Plan.
- Identifying, investigating
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