Milano
Master 1 Level
Italian
12 months
blended
Since the scientific validity of a clinical study depends on the methodological rigor of the protocol, compliance with the procedures it describes, and the quality of the data on which the analysis of results is based, the role of the Data Manager has become increasingly essential across public and private organizations engaged in planning, conducting, and evaluating clinical research. This professional figure is indispensable for carrying out all activities related to the management of clinical data and documents that, throughout a clinical study, must be prepared by investigators, ethics committees, sponsoring companies, CROs, and data processing centers.
Participation in the Master’s program allows students to obtain the Good Clinical Practice ICH-GCP E6 certification.
The overall educational goal of this Master’s program is to provide highly qualified training for the following functions:
The Master’s program is designed to ensure that students acquire:
The 304 hours of lessons planned in the curriculum are delivered as follows:
The majority of lessons are provided remotely in a blended format, either synchronously (via the Webex platform) or asynchronously (through video lectures and exercises made available to students on the Master’s e-learning portal);
Approximately 30% of the lesson and exercise hours—including 28 hours dedicated to REDCap software training and 28 hours to SAS training—are delivered in person in computer-equipped classrooms at the University.
All synchronous remote lessons are recorded and made available to students through the Master’s e-learning portal. Webex streaming recordings are considered supplementary teaching materials and do not replace participation in live synchronous lessons.
304 hours of Lezione
500 hours of Stage/Project Work
The final exam consists of an oral discussion of the internship/project work.
Drug development phases
Types of clinical studies
Experimental designs, observational designs, adaptive designs
Uncertainty in the diagnostic process
Frequency of clinical events
Random and systematic errors in diagnostic measurements
Bias control
Systematic reviews and meta-analyses
Introduction to relational databases
Conceptual design
Logical design
SQL language
Good Clinical Practice (ICH-GCP R3)
Regulatory framework (observational studies and interventional studies with drugs and medical devices)
Ethical and regulatory evaluation and authorization process of a clinical trial
Clinical trial monitoring
Data governance
Quality requirements in clinical trials
Principles of Computer System Validation (CSV) in the GCP context
Elements of project management and performance indicators
Tools for data collection (CRFs/eCRFs, study database, and other important data)
Cleaning of efficacy and tolerability data
Processes for coding drugs and medical terms
Reconciliation of the study database with the pharmacovigilance database (serious adverse events)
Interaction with the study team for study progress control and data quality monitoring
Importance of clinical data management systems
Introduction to the REDCap system: Piping/Smart Variables/TAGs, Branching Logic, Project HOME/SETUP/Applications (tools), randomization
Introduction to SAS programming language
Procedures for data import
Creation of derived variables
Main procedures for data validation
The importance of biostatistics in clinical research
Elements of descriptive and inferential statistics
Methods for analyzing continuous, categorical, and survival outcomes
Introduction to machine learning
Building machine learning pipelines through visual interaction using the OrangeML suite
The Clinical Research Data Manager is a key figure in the planning and conduct of clinical research studies. Their expertise applies to both commercial (Profit) and non-commercial (Non-Profit) research.
This professional role is responsible for managing and coordinating clinical studies, usually at the investigative site. The CRC assists researchers and study staff in planning, organizing, and supervising activities related to clinical studies, while ensuring coordination of activities and maintaining communication with Monitors and Sponsors. Responsibilities include managing study documents, recruiting and managing participants, handling data at the clinical investigative site, communicating with various stakeholders, and monitoring study progress to ensure that all procedures are conducted in compliance with protocols and applicable regulations.
The Clinical Research Associate (CRA), also known as Monitor, is responsible for overseeing clinical studies to ensure they are conducted in compliance with protocols, Good Clinical Practice (GCP), and applicable regulations. This role includes verifying data collection, monitoring ethical and regulatory compliance, and supporting research sites participating in the study to resolve any operational issues. Typically, the CRA works on behalf of the clinical trial sponsor, whether profit or non-profit (e.g., pharmaceutical companies, CROs, non-profit organizations, etc.).
The Master’s program provides the theoretical training required by the decree of November 15, 2011 (known as the CRO decree), as well as the foundational knowledge necessary for this professional activity. However, the practical monitoring experience—mentored alongside an experienced Monitor at clinical research sites—is essential for CRA certification. This hands-on training depends on the host organization where the student undertakes their internship and is rarely guaranteed.
The Clinical Data Manager (CDM) is responsible for the collection and management of data derived from clinical studies and ensures data quality and integrity. This role involves creating and maintaining clinical databases, verifying data quality and integrity, and managing data cleaning and validation processes. The CDM works closely with other members of the research team to ensure that the collected data are accurate, complete, and suitable for statistical analysis and the presentation of research results.
The Clinical Trial Assistant (CTA) is the professional responsible for supporting the Monitor and Project Manager in managing the bureaucratic and documental aspects of a clinical study, in compliance with Good Clinical Practice (GCP), internal Standard Operating Procedures (SOPs), and current regulations.
The role of the Start-Up Specialist, on the other hand, focuses on managing regulatory and authorization processes necessary for the initiation and conduct of a clinical study.
The "Operational Aspects" module of the Master, together with seminars on the practical use of the European Medicines Agency’s (EMA) Clinical Trials Information System (CTIS) platform, enables students to acquire basic regulatory and compliance skills required for entry-level positions in this field.
GIULIA PASTORI
Milano
Executive Course
Italian
33 hours
In presence
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