Clinical Affairs Specialist - Bresso, Italy - ITA 2023-003

Job Title

Clinical Affairs Specialist

Job Facts

Organizational Area
Italy and UK Branch
Country / State
Place of work
Home/Office based
Office based

Professional Family: 

  • Quality
Reporting To
Senior Molecular Clinical Affairs Manager

Kind of contract

Full Time / Part Time
Full Time
Permanent / Temporary
Job ID
ITA 2023-003

Job Scope

Your Mission

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

Main Responsibilities

Your Contributions

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
Verify that fees are regularly payed to Hospitals and Ethical Committees
c) Contracts, Costs and Logistics
d) Project Management

Qualifications Experience Personal Strengths Mobility

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

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


Ability to communicate with external and internal interfaces


Good attitude to work in team

Fluent spoken and written English.
Travel Availability
Relocation Availability
Training Required

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


We Offer You

As per Company Policy