Clinical Project Manager, Global Rare Diseases

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 Global Rare Diseases Chiesi Global Rare Diseases is a Chiesi Group’s business unit established in February 2020 and focused on research, development and commercialization of treatments and patient support services for rare and ultra-rare disorders, many of whom have limited or no treatments available. This unit is based in Boston, Massachusetts, with a strong synergy with the headquarters in Parma. Rare unit has a focus on research and product development for lysosomal storage diseases, rare hematology, ophthalmology disorders and rare immunodeficiencies. The unit is also a dedicated partner with global leaders in scientific research, patient advocacy and care. Discover more here . What we are looking for This is what you will do Responsible for coordinating the operational management of assigned clinical trials according to ICH GCP, Chiesi SOPs and medical, scientific, and regulatory standards Responsible for communicating with multiple stakeholders while the studies or programs are progressing Responsible for budget management and accuracy of invoices for all study payments of assigned clinical trials You will be responsible for Proactively manage operational aspects of assigned clinical trials including study timelines, budget, and resources, working closely with other Core Team Members as applicable Make appropriate operational decisions to ensure that global clinical trials are initiated and completed on time, on budget and in compliance with ICH and GCP requirements Provide clinical operations input to the study team members during the study design and the key steps of the study planning and conduct stages Act as primary contact for internal and external customers, by managing day to date contact or in an oversight capacity based on assigned studies or programs Enable adequate study-specific document preparation and archiving Obtain, evaluate, and coordinate input from multiple internal departments to ensure clinical trial compliance with SOPs Support budget computation and control for assigned clinical studies or programs Support Global GRD QMS for future development of GRD SOPs and other projects as needed You will need to have Bachelor's degree in Life Sciences or equivalent Five or more years clinical research experience, with a minimum of three or more years' experience in global clinical project management with a track record of successful achievements in a similar role in industry or at a CRO Knowledge of principles of clinical study design, planning tools and planning principles, ICH/GCP requirements Strategic thinking Project and Program Management Cost/Benefit Analysis Computer skills required, with proficiencies in Microsoft Applications (Word, Excel, PPT, etc) Location This position is open everywhere in EU, US and Canada. Compensation Range The package outlined below is based on the role being located in Italy. Where the role is offered in a different country, the applicable salary, bonus and benefits will be aligned to the relevant local market and internal frameworks. Full details of the applicable package will be provided at the appropriate stage of the recruitment process. The minimum salary for this role is €46.000, 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, 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.