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About us
Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people's quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas: Discover more here
We are proud to have been awarded with B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels.
We believe that the success of Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors. Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.
We are committed to embrace diversity, inclusion and equal opportunities. In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.
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.
The unit is headquartered in Boston, Massachusetts, and has an initial focus on research and product development for lysosomal storage diseases, rare hematology and ophthalmology disorders. The unit is also a dedicated partner with global leaders in scientific research, patient advocacy and care.
What we are looking for
Purpose
* Responsible for coordinating the operational management of assigned clinical studies or programs according to ICH GCP, Chiesi SOPs and medical, scientific and regulatory standards
* Responsible for communicating with multiple internal and external stakeholders while the studies or programs are progressing
* Support area or department related non-study specific projects as assigned by the Head of Clinical Operations or Head of Clinical Project Manager
* Responsible for budget management of assigned clinical trials or programs
* Accountable for the accuracy of invoices for all study payments
Main Responsibilities
* Proactively manage operational aspects of assigned clinical trials including study timelines, budget and resources, working closely with other Core Team Members as applicable
* Take 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
* Develop and maintain the study-specific roles and responsibilities/RACI grid based on the operational model under which the study is operating
* Prove clinical operations input to the study team members during the study design and the key steps of the study planning and conduction
* Ensure effective study documents and study management plans are in place and operational
* Prepare and lead clinical operations study team meetings
* Proactively plan for and manage study specific risks and issues associated with assigned clinical trials
* Oversee study-specific documentation preparation and archiving in the eTMF
* Act as primary contact for internal and external (CRO) customers, by managing day-to-date contact
* Obtain, evaluate and coordinate input from multiple internal departments/specialists to ensure clinical trials comply with SOPs
* Support QA in study-specific activities and in collaboration in the development, revision, training and implementation of GRD SOPs
* Support QMS activities, including the global GRD integration for GRD SOPs.
* Support budget computation and control for assigned clinical studies or programs
Experience Required
8+ Years clinical research experience, with 3+ years Clinical Project management experience.
Education
BS/BA in Life Sciences or Similar
Languages
English fluent
Technical Skills
Knowledge of principles of clinical study design, planning tools and planning principles, ICH/GCP requirements.
Soft Skills
* Strategic thinking
* Problem solving
* Planning and organizational skills
* Communication skills
* Time management
What we offer
You would join a dynamic, fast-growing, challenging and friendly environment.
In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and collective well-being.
We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.
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