Senior Clinical Project Manager

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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. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. p pAt Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact. /We believe our differences make us stronger. 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 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 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. 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. /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 premio scheme, subject to company and individual performance. /p pIn addition,

we offer
a comprehensive benefits package including pension, private medical insurance, wellb

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8ljxja