Rare Disease Clinical Project Manager

3 settimane fa

Parma, Italia Chiesi Farmaceutici A tempo pieno

**Date**: 29 Feb 2024
**Department**: GRD Clinical Development
**Team**: R&D, Pharmacovigilance & Regulatory Affairs

**Job Type**: Direct Employee
**Contract Type**: Permanent

**Location**:
Parma, IT

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 en

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