Senior Clinical Project Manager

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. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. At 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. 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 doAccountable 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 contractYou will be responsible forTypically 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. 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. 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).
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/planManages the CTS once delivered to sitesEnsures that the trial complies to SOPs and all necessary quality standards. 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 studiesYou will need to haveAt 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 fluentKnowledge 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 literatureLocationThe 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. 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 initiative