05 ago - Milano
Recordati
Data Governance Manager **ID**:1810 **Date of Posting**:Aug 5, 2025 **Business Area**:Research & Development **Job Type**:Direct Employee **On site / Remote / Hybrid**:Hybrid **Location**:Milano, IT **Territory**:
**Full-Time or Part-Time**:Tempo pieno **Seniority**:Mid-senior
- With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and turnover of over Euro 2bn._
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- We are a group of like-minded, passionate individuals who go to extraordinary lengths for our patients, customers, partners, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries._
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- At Recordati, our mantra is simple. We’ve always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest - we want to give people the opportunity to be the best version of themselves._
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- This drive will never stop. Together, we will always be reimagining tomorrow - with new ideas, new technologies and new innovations to fight diseases._
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- Recordati. Unlocking the full potential of life._ **Job Purpose**-
**Key Responsibilities** **Overall Objectives**: - Develop and implement comprehensive data governance frameworks.
- Monitor and ensure the quality, accuracy, and security of clinical trial data.
- Ensure full compliance with relevant data regulations and standards.
- Lead efforts in clinical data cleaning and standardization, ensuring consistency across study sites and systems for accurate analysis and reporting.
- Collaborate with cross-functional teams to promote and embed data governance best practices throughout the organization. **Main Tasks & Responsibilities**: - Implement documented procedures covering the entire data lifecycle, from data capture to final analysis and archiving, ensuring traceability, integrity, and security of data.
- Map and optimize data flow processes across clinical systems (e.g., EDC, CDB, CTMS, SAS), ensuring efficient, traceable, and compliant data movement.
- Support the implementation and governance of Risk-Based Monitoring (RBM) strategies by implementing new systems and analytics across platforms, with a focus on critical data, systems, and processes, including documented risk assessments and mitigation strategies.
- Support vendor oversight activities by reviewing and aligning data governance practices with those of CROs and external data providers (e.g., Central labs, ePRO), ensuring adherence to company SOPs and regulatory standards.
- Develop architecture for the efficient integration of CDMS systems and the wider Clinical suite systems.
- Oversee Data Management activities for clinical trials, including EDC build and system integrations, and lead Data Management efforts where required, providing input into all major documents such as clinical development plans, protocols, data management plans, and case report forms.
- Ensure systems capture and retain metadata, including audit trails, user access logs,
and data modification history, with clear review and retention policies.
- Implement processes to safeguard participant confidentiality, including secure data transfer, access control, and encryption where appropriate.
- Utilize validated or reconciled processes for data transfer and migration between systems, preserving data integrity and traceability, including for newly acquired products.
- Establish processes for identifying, tracking, and resolving data discrepancies and quality issues in collaboration with clinical and data management teams, including root cause analysis and remediation planning.
- Build and coordinate a network of data owners and data stewards across R&D; functions, working with clinical teams, data managers, digital solutions, and other stakeholders to promote data governance best practices and ensure alignment with study objectives.
- Extract, analyze, and report on data to identify trends, patterns, and Key Performance Indicators (KPIs) related to data quality within the clinical trial setting.
- Ensure mechanisms are in place to log and resolve system issues, especially those affecting participant safety or trial outcomes.
- Deliver targeted training and awareness initiatives to internal users (e.g., Clinical Teams, Data Managers, Biostatistics) on data standards, audit trails, and regulatory requirements. **Required Education**
Bachelor’s or Master’s degree in Data Science, Information Management, Life Sciences, Statistics, or a related field.**Required Skills and Experience**
- Minimum of 5+ years of experience in data governance, data management, or related roles within the pharmaceutical or life sciences industry.
- Proficiency with electronic data capture (EDC) systems, data managem
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