Job Title
Job Facts
Professional Family:
- Quality
Kind of contract
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
Main 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
Verify that fees are regularly payed to Hospitals and Ethical Committees
c) Contracts, Costs and Logistics
d) Project Management
MONITORING
Qualifications Experience Personal Strengths Mobility
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.
Background in Clinical Studies Management
Technical Molecular Laboratory skills, GLP
Ability to communicate with external and internal interfaces
Flexibility
Good attitude to work in team
Specific training courses in relation to: US CFR, Title 21, Part 812 - CE IVD-R - GCP
Benefits
As per Company Policy