CLINICAL RISK OPERATION SPECIALIST

Date: 13 Dec 2024 Department: Global Clinical Development 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. 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. 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 adopt and promote a transparent and ethical behavior at all levels. Our success 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. We are a global family made up of different cultures, 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. 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. Main Responsibilities Collaborates with GCD 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) Taylor mitigation actions for risks identified CtQ protocol analysis, propose QTL parameters, chair discussions, and set up risk management within studies Provides clinical risk assessment input during study design meetings and other internal governance meetings. Integrated Quality Risk Management Plan 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 requested by Chiesi Risk Evaluation Committee. Escalates to risk owner(s) any issues impacting the project. Trials closure phase: Reviews the appropriate risk sections of the Clinical Study Report (CSR) and provide the final risk assessment report. 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 believe that our people are our most valuable asset , which is why we invest in continuous training, learning, and development. 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 to give our best. We offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues, and many other people-care services. #J-18808-Ljbffr