What are the responsibilities and job description for the COPD Clinical Project Management Head position at Chiesi?
About us
Based in Parma, Italy, Chiesi is an international research-focused pharmaceuticals 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 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.
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."
* Typically supervises the clinical operations of one programs
* Contributes to the Clinical Development Plan (CDP) definition in relation to the studies' operational aspects and geographic feasibilities (including costs and timelines input on the CDP)
* Participates in the preparation of the documentation for eCTD submissions (e.g., summaries)
* Typically supervises one or more DALs and CPMs involved in different trials
* Supports the DAL and CPM in taking appropriate operational decisions to ensure that projects are initiated and completed on time and on budget, complying with the required quality standards (ICH-GCP, Chiesi Standard Operating Procedures (SOPs) or any local regulations)
* Provides clinical operations input/support to the DAL and CPM during study design, Clinical Protocol Approval Committee (CPAC) preparation
* When appropriate, reports to different stakeholders and Top Management at critical steps of the study conduct
* Involved in the writing/ review of SOPs and working instructions (WI). Completes assigned SOPs/Wls/processes trainings according to company process
* Per forms Line Management responsibilities of Late Phase Clinical Project Managers:
o Ensures adherence to scope of work within timelines and budget
o Ensures the CPM manages the CRO appropriately according to internal standardized processes
o Provides strategic and technical input/ support when needed. Participates to the establishment of mitigation and contingency plans for clinical trials when appropriate
o Identifies strengths and weaknesses for individual development
o Defines yearly objectives and performs periodic assessments, individua l performance evaluations and individual development plans
- Supervises the development of full synopsis and protocol (clinical investigation plan for medical device) based on the Study Outline contained in the CDP and of any other important study-related documentation
- Supports the DALs and CPMs in the selection process for the CRO and/or other service providers, reviews the completed Request For Proposal (RFP), the received proposals and attends the Bid Defense Meetings. Supports the CPM in the preparation of the Scope of Work appendices when applicable, as per the Chiesi guideline/SOP in place
- Acts as escalating contact For CRO and/or other service provider. May help For the review and may provide input For study related documents prepared by CRO
- Supports the DALs and CPM in the preparation and collaboration For scientific meetings: investigators' meeting, scientific/safety board meetings, Data review meetings and any other study-relevant meeting
- Advises the DALs and CPMs when needed to implement corrective/preventive actions and Follow-ups (e.g., in case of audits)
- Prepares in collaboration with the DALs ) the Forecasting For future studies
- Prepares with the DALs and CPM the budget to be validated during the CPAC
- Finalizes the budget with the HLPSM
- Supervises variations of the study budgets compared to Forecast & preclosing. Twice a year, reviews the Forecast & preclosing budgets prepared by t11e CPMs according to study progress
- Supports the CPM in the preparation and review of the Clinical Study Report (CSR) [or Clinical Investigation Report (CIR) For medical devices] in cooperation with the Medical Writer
- Supports the CPM in tl1e review of the layman summaries and study summaries For authorities
- Supports the CPM in the presentation of clinical study results internally and externally (i.e., abstracts/posters preparation and presentation to scientific conferences) as well as the preparation of manuscripts for the full paper publication
Professional experience:
- At least 8 years of experience in a Clinical Research Project Management in a pharmaceutical company or CRO.
- Track record of achievements in successful planning and execution of at least 10 clinical studies.
- A previous managerial experience would be recommended.
Degree in Life Sciences (biological science, pharmacy or other health related discipline) 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, sexual orientation, marital status, veteran status, gender identity or expression or 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.