Job description

Obsessed by Science. Entrepreneurial by Nature. United by Purpose. Diasorin is a global leader in immunodiagnostic and molecular diagnostic solutions, advancing science to improve patient outcomes worldwide. For more than 50 years, we have combined scientific rigor with an entrepreneurial mindset, operating with a strong commitment to innovation, accountability, and results to deliver trusted diagnostic solutions. As the Diagnostics Specialist, Diasorin continuously invests in research, technology, and people. Guided by our values of operational excellence, customer focus, and teamwork, we empower teams to think boldly, act decisively, and transform ideas into meaningful impact across one of the industry’s broadest specialty diagnostic portfolios. When you join Diasorin, you are not just filling a role. You are helping build what comes next. Why Join Diasorin • Build What Matters Take ownership, challenge the status quo, and contribute directly to solutions that improve patient care worldwide. • Innovate with Agility at a Global Scale Work in an entrepreneurial environment that enables speed, collaboration, and global impact. • Grow in a People-Centered Culture Thrive in a culture that values accountability, inclusion, and continuous development. Job Scope This position plays an integral role in the development, sourcing and maintenance of clinical data management tools, database, and software for in vitro diagnostic products. The role involves activities related to ensuring the overall accuracy and integrity of clinical studies data in accordance with applicable global regulations and standards (e.g. 21 CFR Part 812, CLSI, ICH) that demonstrate the performance and utility of in vitro diagnostic products. Key Duties and Responsibilities • Ensure the overall accuracy and integrity of the Clinical Affairs study databases. • Implementing administrative procedures and policies to support database system use. • Maintaining user access to the system and providing initial database training for new users. • Entering new studies into the database and validating new study databases before clinical inputs are performed. • Leading database users in preparing reports, tabulations, CRF preparation and database troubleshooting. • Manage the development of primary and validation programming and lead the report generation activity for clinical trials. • Possessing knowledge of domestic and international clinical requirements including GCP and is able to perform these essential duties and responsibilities with some direct supervision. • Working closely with external Data Management contractors, Clinical Development, Clinical Affairs, the Clinical Trial Managers, Sample Bank team, Legal department, Logistics team, and Marketing teams to ensure project tasks are managed to completion. • Ensure standards for statistical analyses are followed via statistical program validation and quality control activities. • Provide statistical input, develop statistical analysis plan for clinical study protocols. • Manage data management project timelines and schedules for projects within and outside the department. • Select, validate, manage database for clinical data tracking (EDC system) • Responsible for monitoring assigned clinical and outcomes studies to ensure compliance with clinical study protocols, investigator agreements, and applicable corporate regulatory requirements. • Other job duties as assigned, which may include: • Assist in developing departmental SOPs. • Preparation of statistical reports for regulatory submissions, including global, FDA, IRBs or internal customers • Preparation for departmental and executive meetings • Clinical data entry and QC • Case Report Form (CRF) and query management • Select, validate, manage electronic CRF (eCRF) software/database. • Database training for new users; support for current users • Sample data analysis for Product Development teams. • Benchmark study result analysis with Product Development and Marketing teams. • Carry out internal auditing of clinical databases. • Any other duties deemed necessary by management. Education, Experience, and Qualifications • Bachelor's Degree with 5 years’ in Molecular Biology / Biochemistry or related discipline, with experience in a regulated clinical research environment • Master's Degree with 3 years’ or Ph.D. (preferred) in Molecular Biology / Biochemistry or related discipline, with experience in a regulated clinical research environment • Ph.D. with 1 year, in Molecular Biology / Biochemistry or related discipline, with experience in a regulated clinical research environment • Superior communication, presentation and writing skills. • Highly organized with proven time management and prioritization skills • Computer programing skills for clinical data mining is desired. • Experience in molecular and clinical data analysis. • Experience in searching through and understanding scientific and regulatory literature. • Experience in working independently in a fast-paced environment with rapidly changing priorities. • Experience in documentation and record management for laboratory and clinical studies (GLP and GCP) • Experience or knowledge of the requirements on working in a FDA regulated environment. Travel Requirements • 20% 10% international What we offer Receive a competitive salary and benefits package as you grow your career at DiaSorin. Join our team and discover how your work can impact the lives of people all over the world. Diasorin is committed to building a workplace where people feel empowered to contribute ideas, take ownership, and grow their careers. We believe diverse perspectives strengthen innovation and help us deliver meaningful impact for patients and customers worldwide. Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable law. This posting and recruitment process are subject to applicable local laws and regulations in the country where the position is located. Additional employment disclosures, candidate rights, and employment conditions may apply based on local jurisdiction. Individuals hired will be required to verify identity and eligibility to work and may be subject to a background check and drug screening where permitted by law. Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities during the application process. If assistance is required, please contact hr@diasorin.com . Recruitment Fraud Notice Diasorin never requests payment, financial information, or personal banking details from candidates at any stage of the recruitment process. Official communications from Diasorin recruiters will only come from a verified @diasorin.com email address. If you have questions about the legitimacy of a recruitment communication, please contact hr@diasorin.com for verification. Unauthorized third-party recruiting agencies may not submit candidates for this position without prior written authorization from the Diasorin Human Resources Department.

Requirements

Must-haves

Obsessed by Science. Entrepreneurial by Nature. United by Purpose.
When you join Diasorin, you are not just filling a role. You are helping build what comes next.
Why Join Diasorin
Build What Matters
Take ownership, challenge the status quo, and contribute directly to solutions that improve patient care worldwide.
Innovate with Agility at a Global Scale
Work in an entrepreneurial environment that enables speed, collaboration, and global impact.
Grow in a People-Centered Culture
Thrive in a culture that values accountability, inclusion, and continuous development.
Key Duties and Responsibilities
Ensure the overall accuracy and integrity of the Clinical Affairs study databases.
Implementing administrative procedures and policies to support database system use.
Maintaining user access to the system and providing initial database training for new users.
Entering new studies into the database and validating new study databases before clinical inputs are performed.
Leading database users in preparing reports, tabulations, CRF preparation and database troubleshooting.
Manage the development of primary and validation programming and lead the report generation activity for clinical trials.
Possessing knowledge of domestic and international clinical requirements including GCP and is able to perform these essential duties and responsibilities with some direct supervision.
Ensure standards for statistical analyses are followed via statistical program validation and quality control activities.
Provide statistical input, develop statistical analysis plan for clinical study protocols.
Manage data management project timelines and schedules for projects within and outside the department.
Select, validate, manage database for clinical data tracking (EDC system)
Responsible for monitoring assigned clinical and outcomes studies to ensure compliance with clinical study protocols, investigator agreements, and applicable corporate regulatory requirements.
Other job duties as assigned, which may include:

Nice-to-haves

Master's Degree with 3 years’ or Ph.D. (preferred) in Molecular Biology / Biochemistry or related discipline, with experience in a regulated clinical research environment

Application prep

Use the role’s language and application details while tailoring your materials.

Keywords to mirror

gcp

Platform: successfactors
Effort: medium

Benefits

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