Global Biometrics Sciences Functional Excellence Lead

At Alfasigma, we are looking for a GBS Functional Excellence Lead to join our Global Biometrics Sciences (GBS) team. The role will be responsible for defining and maintaining high-quality standards for clinical data and biometrics deliverables, overseeing the development and optimization of processes (SOPs) and ensuring compliance with industry standards and regulatory requirements.

The GBS Functional Excellence Lead will also support the implementation and validation of clinical systems, ensuring their effectiveness and alignment with organizational goals, as well as ensuring smooth and effective vendor management. This position requires a good understanding of clinical data standards, process management, and system integration, with a focus on continuous improvement and operational excellence. Additionally, this role will support training and knowledge-sharing initiatives to ensure that team members remain up to date on the latest standards, processes, new methodologies, and regulatory guidance.

Main Responsibilities:

• Define and maintain standards for clinical data (e.g., CDISC), statistical analysis, and related deliverables to ensure consistency and quality across all biometrics projects.
• Lead the development and continuous improvement of Standard Operating Procedures (SOPs), ensuring efficiency and alignment with regulatory expectations.
• Support the implementation and validation of clinical systems (e.g., EDC, CDMS, statistical software), ensuring alignment with business needs and close collaboration with IT.
• Partner with cross-functional teams (Clinical, Trial Operations, Regulatory, IT) to ensure seamless integration of systems and tools supporting the biometrics function.
• Drive continuous process improvement initiatives to increase operational efficiency, reduce variability, and enhance inspection readiness.
• Ensure compliance with global standards and regulatory guidelines, with a focus on statistical and clinical data deliverables for submissions.
• Provide subject matter expertise and mentoring on biometrics processes, systems, and standards across the organization.
• Promote a culture of knowledge sharing and lead training initiatives to keep teams up to date with evolving methodologies and regulatory changes.
• Monitor industry trends and proactively recommend updates and innovations in biometrics standards and technologies.

Requirements:

• Master’s degree in Life Sciences, Data Science, Statistics, or related field; PhD is a plus
• At least 5 years of experience in biometrics, clinical data management, or related fields
• Strong knowledge of CDISC standards (SDTM, ADaM) and clinical data regulatory requirements
• Proven experience in developing and maintaining SOPs and optimized workflows
• Expertise with clinical systems and statistical software (e.g., SAS, R), and strong understanding of Computerized System Validation
• Solid project management skills, with the ability to lead cross-functional initiatives and manage multiple priorities
• Excellent communication and stakeholder management abilities
• Fluent in English, both written and spoken
• Passion for innovation and continuous improvement within clinical development environments

Location : Italy (Milan, Bologna or Pomezia) or Europe

Company:

Alfasigma is a global pharmaceutical company founded over 75 years ago in Italy, where it is headquartered (in Bologna and Milan). The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa. It has offices in many countries, including Italy, the US, Spain, Germany, Mexico, and China; production sites in Italy (Pomezia, RM; Alanno, PE; Sermoneta, LT; Trezzano Rosa, MI), Spain (Tortosa, Baix Ebre), and the United States (Shreveport, Louisiana); and R&D labs in Italy (Pomezia and Bergamo).

Alfasigma employs approximately 4,000 people dedicated to research, development, production, and distribution of medicinal products, contributing to its mission to provide better health and a better quality of life for patients, caregivers, and healthcare providers. It focuses on three main therapeutic areas: Gastroenterology, Vascular, and Rheumatology. Its portfolio spans from primary care to specialty care, rare disease medications, and consumer health products, including medical foods and nutraceuticals.