Data Management Specialist

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