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About the Role

This position plays an integral role in the development, sourcing, and maintenance of clinical data management tools, databases, and software for in vitro diagnostic products. The role involves ensuring the accuracy and integrity of clinical studies data in accordance with applicable global regulations and standards to demonstrate the performance and utility of in vitro diagnostic products.

Responsibilities

• Ensure the overall accuracy and integrity of the Clinical Affairs study databases.
• Implement administrative procedures and policies to support database system use.
• Maintain user access to the system and provide initial database training for new users.
• Enter new studies into the database and validate new study databases before clinical inputs are performed.
• Lead 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.
• Work closely with external Data Management contractors, Clinical Development, Clinical Affairs, 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 and develop statistical analysis plans for clinical study protocols.
• Manage data management project timelines and schedules for projects within and outside the department.
• Select, validate, and manage databases for clinical data tracking (EDC system).
• Monitor assigned clinical and outcomes studies to ensure compliance with clinical study protocols, investigator agreements, and applicable corporate regulatory requirements.
• Assist in developing departmental SOPs.
• Prepare statistical reports for regulatory submissions, including global, FDA, IRBs, or internal customers.
• Prepare for departmental and executive meetings.
• Perform clinical data entry and QC.
• Manage Case Report Forms (CRF) and queries.
• Select, validate, and manage electronic CRF (eCRF) software/database.
• Provide database training for new users and support for current users.
• Analyze sample data for Product Development teams.
• Benchmark study result analysis with Product Development and Marketing teams.
• Carry out internal auditing of clinical databases.
• Perform any other duties deemed necessary by management.

Requirements

• Possess knowledge of domestic and international clinical requirements including GCP and is able to perform essential duties and responsibilities with some direct supervision.
• Superior communication, presentation, and writing skills.
• Highly organized with proven time management and prioritization skills.
• 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.

Skills

• Molecular Biology
• Biochemistry
• Clinical research
• Database management
• Clinical data management
• In vitro diagnostic products
• 21 CFR Part 812
• CLSI
• ICH
• GCP
• Statistical analyses
• Statistical analysis plan
• EDC system
• eCRF software
• Computer programming for clinical data mining
• Molecular and clinical data analysis

Location

• Global

Work Type

• Full-time

Experience Level

• 5 years
• 3 years
• 1 year

Education Level

• Bachelor's Degree
• Master's Degree
• Ph.D.

Benefits

• Competitive salary and benefits package

About the Company

• Diasorin is a global leader in immunodiagnostic and molecular diagnostic solutions, advancing science to improve patient outcomes worldwide.
• For more than 50 years, Diasorin has combined scientific rigor with an entrepreneurial mindset, operating with a strong commitment to innovation, accountability, and results to deliver trusted diagnostic solutions.
• Diasorin continuously invests in research, technology, and people.
• Guided by values of operational excellence, customer focus, and teamwork, Diasorin empowers teams to think boldly, act decisively, and transform ideas into meaningful impact across one of the industry’s broadest specialty diagnostic portfolios.
• Diasorin is committed to building a workplace where people feel empowered to contribute ideas, take ownership, and grow their careers.
• Diasorin believes diverse perspectives strengthen innovation and help deliver meaningful impact for patients and customers worldwide.

Equal Opportunity

• 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.