Clinical Studies Specialist - Saluggia, Italy - ITA 2022-010

Job Title

Clinical Studies Specialist

Job Facts

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

Professional Family: 

  • Operations
Reporting To
Clinical Affairs Manager

Kind of contract

Full Time / Part Time
Full Time
Permanent / Temporary
Permanent
Job ID
ITA 2022-010

Job Scope

Your Mission

The overall objective of the position is to plan, implement and monitor clinical studies intended to demonstrate the diagnostic performance of biological markers

Main Responsibilities

Your Contributions

PLANNING AND SET UP
a) Clinical protocol
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
b) Docs for Ethical Committees
Interacts with Ethical Committees to agree upon required documents
Prepares all relevant documents
Negotiates Ethical Committees fees
c) Contracts, Costs and Logistics
Interacts with Clinical Administration to define contracts and fees
Organizes the logistics of samples collection and delivery for testing
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.
INITIATION
Submits all relevant docs to Ethical Committees and follow up
Verify that fees are regularly payed to Hospitals and Ethical Committees
Organizes meetings with Clinical Investigators to open the study
MONITORING
Regularly interacts (and visits if needed) with Clinical Sites to monitor recruitment, reporting any actual or potential delay

Qualifications Experience Personal Strengths Mobility

You
Education
Bachelor degree or a professional qualification of an equivalent or higher standard, scientific and technical.
Specialization
Masters degree in Statistics or Biotechnology 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
  • Statistical analysis knowledge
Skills
  • Ability to relate with external and internal interfaces
  • Flexibility
  • Good attitude to work in team
Languages
Fluent spoken and written English.
Travel Availability
Some travels may be requested
Relocation Availability
N/A
Training Required

Induction Program Once Hired

Benefits

We Offer You

As for Company Policy