Clinical Project Manager, Global Rare Diseases

About us

Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals and healthcare group with 90 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 research, develops and markets innovative drugs in its three therapeutic areas: AIR (products and services that promote respiration, from new-born to adult populations), RARE (treatment for patients with rare and ultra-rare diseases) and CARE (products and services that support special care and consumer-facing self-care).
We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes transparent ethical behavior at all levels. 
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 USA

Chiesi USA is a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent specialty and rare disease markets. We are a B Corp™ and Benefit company awarded Top Employer status for six consecutive years and certified as a Great Place to Work. 
At Chiesi, we share an entrepreneurial spirit and act as a force for good, pursuing high social and environmental standards, to ensure the wellbeing of our people, patients, and communities. We offer a work environment where professionals have the opportunity to build a purposeful career focused on helping others while achieving a fulfilling work-life balance, meeting exciting challenges, and engaging in important and rewarding work.

Who we are looking for

Purpose

• 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

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
• 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  

Experience Required

• 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)

Education

Bachelor’s degree in Life Sciences or equivalent

Compensation Data

The annual base pay for this position ranges from $120,420 to $147,180. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. If hired, the employee will be in an “at-will position” and