Clinical Risk Operation Specialist

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Team: R&D, Pharmacovigilance & Regulatory Affairs

Job Type: Direct Employee

Contract Type: Permanent

Location:

Parma, IT

About us

Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 31 countries with more than 7,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas: Discover more here

We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels.

We believe that the success of Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors. Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.

In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.

Chiesi Research & Development

Our R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management. Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden), Toronto (Canada) and Shanghai (China).

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

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
• Planning and organizational skills
• Problem solving

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.