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Manager, Clinical Data Management

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Alfasigma

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Location:
Italy , Milano

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Category:
IT - Administration

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

The Manager – Clinical Data Management (CDM) is a senior functional expert in Clinical Data Management, supporting data-related activities at both study and program levels. At the study level, the role supports the Clinical Study Team (CST) by managing and overseeing outsourced data management activities across all phases of clinical trials, including planning, start-up, conduct, and close-out. At the program level, the CDM collaborates with study Data Managers to define and implement aligned data strategies, ensuring consistency, quality, and compliance across studies.

Job Responsibility:

  • Providing data management expertise during protocol development and amendments
  • Contributing to the selection of CROs and specialized vendors for data collection and management
  • Supporting the preparation and review of RFPs related to data management services and costs
  • Acting as the primary point of contact for CROs and vendors, ensuring high-quality deliverables within agreed timelines and budget
  • Ensuring compliance with company processes, ICH E6 guidelines, and applicable regulations
  • Collaborating on study timelines from start-up through close-out
  • Supporting the development, review, and testing of data collection tools (e.g., eCRFs, eCOA systems)
  • Contributing to the creation and maintenance of data management documentation (e.g., DMPs, Edit Check Specifications, Data Validation Plans)
  • Overseeing outsourced data management activities, including data cleaning, coding, and reconciliation
  • Maintaining oversight documentation and coordinating internal data quality reviews
  • Organizing data management meetings and ensuring proper documentation of minutes
  • Ensuring timely and accurate filing in the Trial Master File (TMF) and proper data archiving
  • Serving as a key point of contact in program-level meetings
  • Collaborating with study Data Managers to define consistent and compliant data strategies
  • Monitoring program-level milestones, risks, and mitigation plans to ensure consistent data quality and delivery
  • Actively participating in Data Management and Global Biometrics Science team meetings
  • Collaborating closely with Biostatistics, Medical, Clinical Operations, and other stakeholders
  • Communicating effectively with CROs, vendors, and internal teams
  • Contributing to process improvement initiatives and data strategy development
  • Providing mentorship and guidance to junior CDMs when applicable
  • Ensuring all data management activities comply with company SOPs, ICH E6, and applicable regulatory requirements (e.g., FDA, EMA)
  • Adhering to internal policies and completing required training on time
  • Supporting audits and inspections, and managing CAPA follow-ups in collaboration with Quality & Compliance

Requirements:

  • Minimum of 7 years of experience in Clinical Data Management within pharma, biotech, CRO, or academic settings
  • Bachelor’s degree in life sciences, health informatics, pharmacy, computer science, or a related field
  • Strong understanding of clinical trial processes and data management principles
  • Experience with EDC systems (e.g., Medidata Rave, Veeva EDC)
  • Expertise in eCOA and RTSM systems
  • Familiarity with data visualization tools
  • Proficiency in statistical software (e.g., SAS)
  • Knowledge of regulatory requirements and CDISC standards
  • Strong organizational and communication skills
  • High attention to detail
  • Ability to manage multiple priorities effectively
  • Team-oriented mindset with cross-functional collaboration skills
  • Eagerness to learn and adapt to new systems and processes
What we offer:
  • Competitive salary
  • Comprehensive benefits
  • Extensive opportunities for professional growth and development

Additional Information:

Job Posted:
March 25, 2026

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