Senior Clinical Project Manager

ppSelect how often (in days) to receive an alert: /p pBusiness Area: RD, Pharmacovigilance Regulatory Affairs /p pJob Type: Direct Employee /p pContract Type: Permanent /p pLocation: Parma, IT /p pbAbout us /b /p pChiesi 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. /p pAt 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. /p pDiversity 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. /p pbChiesi Research Development /b /p pOur RD 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, RD 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). /p pbWho we are looking for /b /p h3bThis is what you will do /b /h3 ul liAccountable for coordination of the operational management of assigned projects in order to develop compounds in line with Chiesi goals and medical/scientific standards. /li liAccountable for communication to all stakeholders on the progress of the study /li liAccountable to maintain and respect budget according to study signed contract /li /ul h3bYou will be responsible for /b /h3 ul liTypically manages 1-3 clinical trials, depending on size, complexity, phase of development and therapeutic area. /li liResponsible for management of the Clinical CRO/Providers /li liActing as primary contact for Clinical (CRO) but also internal customers; /li lirepresenting the Study Team for operational part of the clinical trials allocated to her/him. /li liEnsures adherence to scope of work within timelines and budget. /li liReviewsstudy 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. /li liCollaborates in the set-up and maintenance of the Study Risk Register. Responsibleclinical risk review involving all relevant study team functions and for the follow-up on actions with vendors (CRO, direct and third-party vendors). /li liResponsible for the management of the study eTMF (related to clinical operations)with the Clinical Trial Administrator (CTA). /li liPrepares and coordinates/collaborates to scientific meetings: investigators’ meeting, scientific/safety board meetings, Data reviews and any other relevant meeting(s). /li liManages the preparation of experts/KOLs contract if any (when expert is dedicated to the study). /li liStudy results and related deliverables: br/-Prepares reviews he Clinical Study Report (CSR) in cooperation with the Medical Writer, and its approval. br/-Supports and/or coordinates the presentation of clinical study results internally and externally /li liClinical Trial Supplies: /li liliaises with Clinical Trial Supply (CTS) coordinator to define the CTS strategy/plan /li liManages the CTS once delivered to sites /li liEnsures 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). /li liProvides clinical operations input during study design, Clinical Protocol Approval Committee (CPAC), Extended Clinical Team Meetings /li liBudget Management /li liprepares and presents budget in collaboration with Clin Ops Lead /li liaccountable for budget management for the ongoing studies /li /ul h3bYou will need to have /b /h3 ul liAt least 3 years of experience in a similar position in a pharmaceutical company. /li liTrack record of achievements in successful planning and execution of at least 5 clinical studies. /li liDegree in Life Sciences (biological science, pharmacy or other health related discipline) or equivalent. /li liKnowledge of principles of clinical study design /li liKnowledge of principles of Clinical Research Statistics /li liKnowledge of planning tools and planning principles /li liKnowledge of ICH/GCP and company SOPs /li liKnowledge of GLP for bio analytical assays (for Clinical pharmacology studies) /li liFamiliar and up to date with relevant literature /li /ul h3bLocation /b /h3 pThe position is based at our headquarters in Parma and offers flexible working arrangements, including both hybrid and predominantly remote options. /p h3bCompensation range /b /h3 pThe 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. /p pFinal offer may vary based on the selected candidate's skills, experience, qualifications, overall profile, and internal equity considerations. /p pThis role is eligible toparticipatein an annual bonus scheme, subject to company and individual performance. /p pIn addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme and more. /p pbWhat we offer /b /p pNo 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. /p pWe 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. /p pChiesi 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. /p /p #J-18808-Ljbffr