Data Governance Manager

Job Purpose

Recordati is seeking a Data Governance Manager to play a critical role in ensuring the integrity, security, and usability of data within R&D Operations. This position is responsible for developing and implementing robust data governance frameworks, policies, and standards. The successful candidate will support regulatory compliance, enhance operational efficiency, and facilitate strategic decision-making within our pharmaceutical environment, bringing a strong background in Data Management and trend analyses.

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 management software, and statistical analysis tools.
• Strong understanding of GxP, GDPR, HIPAA, 21 CFR Part 11 requirements, Computer System Validation (CSV) processes, and other relevant data privacy and compliance frameworks.
• Experience managing cross-functional projects and driving organizational change.
• Hands-on experience with data governance platforms and Data Quality management tools.
• Knowledge of operational clinical data (e.g., from CTMS, eTMF, CDMS, RTSM) and its integration into centralized data repositories.

Technical Competencies

• Comprehensive understanding of theoretical and applied statistics.
• Knowledge and use of SAS system.
• Knowledge of CDISC standards, including CDASH and SDTM.
• Strong analytical skills: ability to analyze complex data issues, identify and resolve data quality issues, analyze data trends, and develop actionable solutions.

Required Behaviours and Competencies

• Strong adaptability to evolving project requirements, guidelines, and industry standards.
• Proven ability to work either independently or in a team.
• Excellent written and verbal communication skills, with the ability to influence, collaborate across functions, and report project details clearly to various stakeholders.
• Demonstrated ability to anticipate and resolve problems on projects.
• Commitment to continuous professional development, to stay updated on the latest developments in scientific research.

Required Languages

Fluent English (oral and written).