Clinical Data Scientist

Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years, we've earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world.

Our broad offering of diagnostic tests and Licensed Technology solutions, made available thanks to ongoing investments in research, positions us as the player with the widest range of specialty solutions in the sector and identifies us as the "Diagnostics Specialist."

Why Join Diasorin?

• Impactful Work: When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world.

• Global Reach & Innovation: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry.

Diverse and Inclusive Culture: We believe in the strength of diversity, and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive, collaborative environment where everyone can thrive.

Join Our Team: If you're passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin is the place for you. We're looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward.

Are you ready to be part of a dynamic team that's shaping the future of diagnostics? Join Diasorin and become a catalyst for change in the world of healthcare. Apply today and be a part of our exciting journey toward a healthier, more connected world. Together, we can make an impact!

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 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, or protected veteran status, and will not be discriminated against on the basis of disability.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire.

Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process, please contact the North America Talent Acquisition Team at hrtalent@diasorin.com or 1-800-328-1482 to request an accommodation.

The above job description is intended to describe the general content, identify the essential functions, and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.

Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations.

Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen, subject to applicable laws and regulations.

This position is not eligible for partnership with a third-party search firm vendor without expressed, written consent from the Diasorin Human Resources Department.