Clinical Studies Specialist Montà

Clinical Studies Specialist
Montà
Piemonte, Montà

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