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.
Job Scope
The overall objective of the position is to.
Conduct day-to-day work associated with analytical and clinical studies conducted by DiaSorin Group for inclusion in regulatory submissions for in vitro diagnostic devices.




Plan and execute of in-house clinical studies as well as training and monitoring of external clinical sites.
Acquire clinical specimens for inclusion in research or clinical studies
Key **Responsibilities**:
PLANNING AND SET UP
a) Site Qualification and Clinical protocol
Day-to-day “hands on” work associated with in-house clinical studies
Qualification and monitoring of external clinical sites in accordance with study protocols and applicable regulations and standards (eg. 21 CFR Part 812, GLP, CLSI, ICH)
Ensure studies are carried out according to the study protocol, standard operating procedures (SOPs), and International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) regulations and study specific manuals and procedures
Contributes to discussions with Clinical Investigators
Writes the protocol in close collaboration with Principal Investigators and the internal interested parties
Submits the final protocol to all Clinical Investigators for approval
Organizes meetings with Clinical Investigators to open the study
b) Docs for Ethical Committees
Interacts with Ethical Committees to agree upon required documents
Prepares all relevant documents
Negotiates Ethical Committees fees Submits all relevant docs to Ethical Committees and follow up
Verify that fees are regularly payed to Hospitals and Ethical Committees
c) Contracts, Costs and Logistics




Interacts with Clinical Administration to define contracts and fees
Coordinate and track clinical supplies shipped and used at clinical sites
Contributes to negotiations with Clinical Sites for costs/patient
d) Project Management
Prepares and updates the global Study Project Management Plan with timelines, check points and milestones.
Contribute to the writing of SOPs, DMRs, BPRs
Interact with other LMD departments and external service providers, if required (eg. Sequencing facilities, CROs)
MONITORING
Ensure studies are carried out according to the study protocol, standard operating procedures (SOPs), and International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) regulations and study specific manuals and procedures
Develop and maintain good working relationships with Principal Investigators and Study Staff
Regularly interacts (and visits if needed) with Clinical Sites to monitor recruitment, reporting any actual or potential delay
Create clinical study document designs and tracking tools
Train and provide technical support (trouble shooting) to external sites
Investigate queries, monitor discrepancies and manage investigational device accountability and reconciliation processes
Monitor printed Case Report Forms (CRFs) and Electronic Data Capture (EDC)
Collection and analysis of experimental data generated in-house and externally
Maintenance of study documentation and data history files
Verifies that Clinical Sites correctly prepare, collect and send out the clinical samples for testing
Manage/perform sample aliquot preparation, testing and shipment as needed.
In collaboration with the Principal Investigator and internal interested parties prepares reports and slides to present the study results to Management.
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📌 Molecular Clinical Affairs Associate (Bresso)
🏢 Diasorin
📍 Bresso