Senior Clinical Project Manager

Job description

About us Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here. At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact. Diversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better. 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 This is what you will do Accountable for coordination of the operational management of assigned projects in order to develop compounds in line with Chiesi goals and medical/scientific standards. Accountable for communication to all stakeholders on the progress of the study Accountable to maintain and respect budget according to study signed contract You will be responsible for Typically manages 1-3 clinical trials, depending on size, complexity, phase of development and therapeutic area. Responsible for management of the Clinical CRO/Providers Acting as primary contact for Clinical (CRO) but also internal customers; representing the Study Team for operational part of the clinical trials allocated to her/him. Ensures adherence to scope of work within timelines and budget. Reviews study related documents prepared by CRO (project plan, monitoring plan, risk management plan, site contracts when required,…). Performs co-monitoring when needed, as specified in SOP. Collaborates in the set-up and maintenance of the Study Risk Register. Responsible clinical risk review involving all relevant study team functions and for the follow-up on actions with vendors (CRO, direct and third-party vendors). Responsible for the management of the study eTMF (related to clinical operations) with the Clinical Trial Administrator (CTA). Prepares and coordinates/collaborates to scientific meetings: investigators’ meeting, scientific/safety board meetings, Data reviews and any other relevant meeting(s). Manages the preparation of experts/KOLs contract if any (when expert is dedicated to the study). Study results and related deliverables: - Prepares & reviews he Clinical Study Report (CSR) in cooperation with the Medical Writer, and its approval. - Supports and/or coordinates the presentation of clinical study results internally and externally Clinical Trial Supplies: liaises with Clinical Trial Supply (CTS) coordinator to define the CTS strategy/plan Manages the CTS once delivered to sites Ensures that the trial complies to SOPs and all necessary quality standards. Responsible for corrective and preventive actions and follow-ups (e.g. in case of audits). Provides clinical operations input during study design, Clinical Protocol Approval Committee (CPAC), Extended Clinical Team Meetings Budget Management prepares and presents budget in collaboration with Clin Ops Lead accountable for budget management for the ongoing studies You will need to have At least 3 years of experience in a similar position in a pharmaceutical company. Track record of achievements in successful planning and execution of at least 5 clinical studies. Degree in Life Sciences (biological science, pharmacy or other health related discipline) or equivalent. English fluent Knowledge of principles of clinical study design Knowledge of principles of Clinical Research Statistics Knowledge of planning tools and planning principles Knowledge of ICH/GCP and company SOPs Knowledge of GLP for bio analytical assays (for Clinical pharmacology studies) Familiar and up to date with relevant literature Location The position is based at our headquarters in Parma and offers flexible working arrangements, including both hybrid and predominantly remote options. Compensation range The budgeted salary range approved for this role is between €52.000 and €65.000. This range reflects the typical compensation expected for candidates with the experience and expertise required for the position. Final offer may vary based on the selected candidate's skills, experience, qualifications, overall profile, and internal equity considerations. This role is eligible to participate in an annual bonus scheme, subject to company and individual performance. In addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme and more. What we offer No matter where your path starts at Chiesi, it leads to inspiring possibilities. Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way. We provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market. Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive. Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination.