Senior Clinical Project Manager

Select how often (in days) to receive an alert:Business Area: R&D, Pharmacovigilance & Regulatory AffairsJob Type: Direct EmployeeContract Type: PermanentLocation: Italy, ITAbout usChiesi 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 & DevelopmentOur 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 forThis 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 studyAccountable 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/ProvidersActing 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 externallyClinical Trial Supplies:liaises with Clinical Trial Supply (CTS) coordinator to define the CTS strategy/planManages the CTS once delivered to sitesEnsures 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 MeetingsBudget Managementprepares and presents budget in collaboration with Clin Ops Leadaccountable 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.Knowledge of principles of clinical study designKnowledge of principles of Clinical Research StatisticsKnowledge of planning tools and planning principlesKnowledge of ICH/GCP and company SOPsKnowledge of GLP for bio analytical assays (for Clinical pharmacology studies)Familiar and up to date with relevant literature
LocationThe position is based at our headquarters in Parma and offers flexible working arrangements, including both hybrid and predominantly remote options.Compensation rangeThe minimum salary for this role is €54.000, aligned to our established salary framework. The final offer will reflect the candidate’s skills, experience, qualifications 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, ticket restaurant and more.What we offerNo 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.#J-18808-Ljbffr