Data Management Specialist
Descrizione dell'offerta
Data Management Specialist
Overview
The Data Management Specialist will join Global Clinical Science department of Menarini Stemline, the R&D organisation of the Menarini Group. As a Data Management Specialist, you will develop and maintain the eCRF and other data collection tools in line with clinical trial protocols, regulatory requirements, and standards (e.g., CDISC/CDASH).
You will manage system access, provide guidance for data collection, oversee the process, perform data validation (review, queries, etc.), and generate final standardized datasets (e.g., CDISC/SDTM) suitable for analysis.
Main Activities & Responsibilities
- Responsibility for data management documents of assigned Phase I-III clinical trials;
- Support, review and supervision of all internal or outsourced data management activities for assigned clinical trials;
- Main contact for external vendors for all data transmission or data collection, including, but not limited to: external labs, IRT, eCOA;
- Design of the eCRF;
- Programming of SDTM datasets;
- Contribute to maintenance of internal procedures relating to data management activities.
Job Requirements
- Master degree in scientific disciplines (statistical sciences, biology, computer science, mathematics, pharmacy, CTF).
- Experience of at least 3-5 years in the role of Clinical Data Manager.
- Fluency in English.
- In order to perform the role in the best possible way, the necessary technical knowledge required are:
- Knowledge of CDISC standards (i.e .: CDASH, SDTM);
- Knowledge of C / C # language;
- Knowledge of data collection systems (i.e .: eCRF, IRT, eCOA);
- Knowledge of SAS base;
- Knowledge of the main guidelines (EMA / FDA).
Menarini Stemline is an equal-opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees