Molecular Clinical Affairs Associate

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

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 Duties and 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
• Track and report on progress of studies including site activation, subject enrollment, monitoring visits and close out visits
• 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.
• Collects the data to be used for statistical analysis (internal or consultant)
• Contributes to evaluation, interpretation of results and clinical report preparation

Education, Experience, and Qualifications 

Bachelor degree or a professional qualification of an equivalent or higher standard, scientific and technical.

Specialization:

Previous work experience with analytical or method validation studies, preferably in GLP/GMP laboratory with an understanding of documentation requirements

Previous Clinical Research Associate experience will be a plus 

Experience:

Minimum 3 years work experience in the health care and science industry, preferably with diagnostic, medical devices or pharmaceutical Companies, with knowledge of relevant device technologies and related design processes.

Technical Competencies:

Background in Clinical Studies Management

Technical Molecular Laboratory skills, GLP

Skills:

Ability to communicate with external and internal interfaces

Flexibility

Good attitude to work in team

Languages:

Fluent spoken and written Italian and English

Travel availability:

Travels may be required 

Training required:

Specific training courses in relation to: US CFR, Title 21, Part 812 - CE IVD-R - GCP

Hybrid work

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.