Clinical Risk Operation Specialist

Who we are looking for

Purpose

To support and facilitate the clinical risk assessment and management activities in GCD clinical studies in compliance with regulations and guidelines (including escalation and specific reporting).

Main Responsibilities

• Collaborates with GCD (Global Clinical Development Dept) clinical study teams for:
• Quality-by-design principles in GCD protocols
• Identification of critical to quality factors (CtQ) of GCD protocols leading to setup of Quality Tolerance Limits (QTLs) in clinical studies
• Taylor mitigation actions for risks identified
• CtQ protocol analysis, to propose QTL parameters to study teams and to chair team discussions, QTL specification plans or study specific risk assessments and set up of risk management within studies (Study risk registers, set up of Key Risk indicators, Central monitoring strategy)
• Provides clinical risk assessment input during study design meetings and other internal governance meetings when required.
• Integrated Quality Risk Management Plan and related Study functional plans review and input from risk-based approach
• Interactions with risk-based system experts from CRO for setup and go-live

Reporting

• Reports overall risks review analyses on GCD programs and/or studies.
• Risk Review activities (monthly per study at least)
• Responsible to control the status of any mitigation plans specifically requested by Chiesi Risk Evaluation Committee in response to issues raised by clinical risk management.
• Escalates to risk owner(s) any issues impacting the project and requiring GCD decisions as per escalation or communication plans/procedures

Trials closure phase:

• Reviews the appropriate risk sections of the Clinical Study Report (CSR) and provide the final risk assessment report as appendices if appropriate
• Ensures Risks review lesson learnt dissemination within GCD collaborators

Experience Required

3-5 years of experience in Clinical Research oversight and risk assessment operations in a pharmaceutical company.

Education

High level scientific degree (i.e. pharmacy, biology).

Languages

English fluent.

Technical Skills

• Knowledge of ICH / GCP, regulatory frame
• Knowledge of principles of Clinical Research
• Knowledge of therapeutic areas
• Knowledge of risk assessment and analytics tools

Soft Skills

• Analytical skills
• Communication skills
• Planning and organizational skills
• Problem solving
• Team working

What we offer

You would join a dynamic, fast-growing, challenging and friendly environment.

In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.

We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.