Job Description

Alfasigma is a privately held global healthcare company founded over 75 years ago in Italy, where it remains headquartered today in Bologna and Milan. The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa.

Over three years ago, we embarked on a transformative journey to become a truly global innovative healthcare company with a leading focus on Gastrointestinal (GI) health We have experienced remarkable growth, nearly doubled our revenues, expanding geographically, and integrating several key acquisitions. We have also evolved our portfolio, expanded into rare and specialty segments, and strengthened our pipeline and people's capabilities.

But our journey is far from complete! In fact, this is just the beginning of a bold new chapter in Alfasigma's history. We are committed to advancing innovation and leveraging our deep expertise to provide better health and a better quality of life for patients and consumers worldwide and expand our reach across diverse markets.

Scope of the Role

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.

Your Role

In this position, you will be responsible for:

Clinical Study Support

• 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

Clinical Program Support

• 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

Collaboration & Communication

• 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

Compliance

• 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

Who You Are

Experience & Education

• 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

Technical Skills

• 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

Soft Skills

• 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

Why Join Alfasigma:

At Alfasigma, we foster a culture where the courage to innovate is key to our success.
We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development.

Our commitment to people and patients is at the heart of everything we do. We value diversity and welcome individuals with unique perspectives and experiences. We believe that open-mindedness, collaboration, and a shared passion for innovation are essential to achieving meaningful progress.

Join Alfasigma and become part of a forward-thinking team dedicated to shaping the future of the pharmaceutical industry.