Clinical Data Manager

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7hp9kt

ppLB Research is a Contract Research Organization (CRO) founded in ****, 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.
/ppbClinical Data Manager /b /ph3Job Overview /h3pWe 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.
/ph3Key Responsibilities /h3pThe Clinical Data Manager will be responsible for: /ppDatabase and eCRF Design: /pulliDefining the database structure and layout for paper CRFs and electronic CRFs (eCRFs).
/liliReviewing and verifying CRF/eCRF layouts.
/liliDefining and implementing eCRF and database validation checks, where applicable.
/liliCreating and maintaining annotated CRFs.
/li /ulpData Management Planning: /pulliPreparing and updating the Data Management Plan (DMP) in collaboration with the Study Project Manager.




/liliPreparing and maintaining the Edit Check Plan for both paper CRF and eCRF studies.
/li /ulpData Processing and Quality Control: /pulliSupervising data entry activities and ensuring the accuracy of data entered into the database.
/liliPerforming or overseeing database reconciliation activities, including double data entry reconciliation when applicable.
/liliPerforming or supervising data cleaning activities according to the Edit Check Plan.
/liliIdentifying, investigating, and resolving data discrepancies to ensure data quality and compliance.
/li /ulpDatabase Review and Lock: /pulliPreparing Data Management documentation and participating in review meetings.
/liliConducting database lock activities according to study procedures.
/liliExporting and transferring final databases to the Statistician and/or Sponsor for statistical analysis.
/li /ulh3Qualifications and Experience /h3ulliBachelor's degree in Life Sciences, Statistics, Health Sciences, or a related field (preferred).
/lili1-3 years of experience in Clinical Data Management within the pharmaceutical, biotechnology, CRO, or clinical research environment.
/liliExperience with eCRF-based studies.
/li /ulh3Knowledge and Technical Skills /h3ulliGood knowledge of clinical research processes and Clinical Data Management principles.
/liliGood knowledge of Good Clinical Practice (GCP) guidelines and data integrity principles.
/liliGood knowledge of SQL and SAS.
/liliFamiliarity with clinical databases and Electronic Data Capture (EDC) systems.
/li /ul /p #J-*****-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7hp9kt