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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 awardedB 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 toembrace 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. What we offer Chiesi offers competitive benefits, services, and programs that enrich the personal and professional lives of our employees. Our shared values of passion, innovation, trust and integrity bring out the individual talents and diverse perspectives of each of our colleagues. Our environment encourages each individual to reach his or her full potential and drive outstanding results. We celebrate that "Every one of us is different. Every one of us is Chiesi." Who we are looking for
Purpose
- Accountable 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 study
- Accountable to maintain and respect budget according to study signed contract
- Ideal candidate will be located in Eastern Time Zone
Main Responsibilities
- Making appropriate operational decisions to ensure that clinical trials are initiated and completed on time, on budget and to the required quality standards, securing compliance ICH and Chiesi SOPs.
- Providing clinical operations input to Clinical Program Leader and study team members during study design, Protocol Review Committee and critical steps of the study conduct.
- Study documents:
- Developing full protocol from the Study Outline contained in the CDP, involving all relevant contributors/accountable persons (Clinical Research Physician, Clinical Pharmacologist, statisticians, Cl.Ph.Vig. Health Economics consultant, data manager, CTS coordinator etc.)
- Managing e-doc process for relevant study documents. Register the study in clinical trial.gov. Responsible for preparation of study documents for e-submissions
- Collaborates with relevant contributors and accountable team members to ensure timely production and review of study-related documentation (IMPD, Insurance certificate, EUDRACT form, CRF, Statistical Analysis Plan, Data Management Plan, CSR etc.), and giving his/her professional support to the planning and organisation of investigator meeting and/or scientific/safety board meetings, Data Safety Reviews, Blind reviews and any other study-relevant meeting.
- Clinical Trial Supplies: Liaising with CTS coordinator to assess needs for drug supply, completion of the CTS request form, place orders with relevant departments in due time, and agree with CTS primary & secondary packaging, use of IVRS, shipment to depot or to investigational site(s), management of study drugs labels / study drug leaflets. If applicable he/she might delegate to CTA.
- Obtaining, evaluating and coordinating required input from all internal departments/specialists to ensure clinical trials comply with SOPs and all necessary standards, as detailed below. Giving input in the Chiesi system to track study audits.
- Study Budget Studies to start within a year:
- Prepares in collaboration with LSHM and Outsourcing Manager the budget to be validated during the PRC.
- Prepares in collaboration with LSHM forecast for studies that are planned within the year but have not reached the stage of PRC at the time of forecast/pre-closing.
- Ongoing Studies:
- Responsible of reconciling original budget with actual charged ensuring that invoices received are checked and correspond to actual expenses done (approved or challenge them until approved). Twice a year provides forecast & budget revision according to study progress (March/April & August/September)
- CRO and/or Providers selection: contributing to their selection by completing the RFP and review the proposals/contracts as per the Chiesi guideline/SOP in place.
- Acting as primary contact for internal or external (CRO) customers, for operational part of the clinical trials allocated to them. Managing day-today relationships, raising issues as soon as they are identified.
- Is accountable for the clinical study archiving as per Chiesi SOP.
- Typically manages 1-3 clinical trials at any one time, depending on size, complexity and phase of development, ideally focused on a single multiple therapy area.
- When applicable responsible of presenting clinical study results internally and externally (i.e. scientific conferences)
- For Clinical pharmacology studies:
- Acting as the scientific lead person for development and validation of bioanalytical methods as well as routine study sample analysis. Responsible for managing projects ensuring compliance with GLP practices.
Experience Required
- At least 3 years of experience in a similar position in a pharmaceutical company or CRO.
- Track record of achievements in successful planning and execution of at least 5 clinical studies.
- Knowledge of principles of clinical study design
- Knowledge of principles of Clinical Research Statistics
- Knowledge of planning tools and planning principles
- Knowledge of ICH/GCP and company SOPs
- Knowledge of GLP for bio analytical assays (for Clinical pharmacology studies)
Education
Degree in Life Sciences or equivalent. Chiesi USA is an equal opportunity employer committed to hiring a diverse work force at all levels of our business. All qualified applicants receive consideration for employment without regard to race, national origin, age, sex, religion, disability, marital status, veteran status, any other basis protected by local, state or federal law. This policy applies with regard to all aspects of one's employment, including hiring, transfer, promotion, compensation, eligibility for benefits and termination.
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Chiesi
Jun 14, 2025