Late Phase Clinical Operations Lead
il y a 4 jours
Chiesi est un groupe familial pharmaceutique italien proposant des solutions thérapeutiques innovantes aux patients du monde entier, principalement dans les domaines respiratoires.
Regroupant 6.000 collaborateurs dans le monde, Chiesi est présent en France sur l’ensemble de la chaîne de valeur ajoutée : Recherche et Développement, Production & Distribution et mise à disposition des Médicaments avec plus de 350 collaborateurs pour un chiffre d’affaires de 120 M€ en 2020.
Le groupe Chiesi a obtenu la certification B Corporation qui souligne l’engagement de l’entreprise dans l’amélioration de la qualité de vie des patients, de manière responsable et durable envers la société et l’environnement.
Depuis avril 2021, Chiesi est le premier laboratoire pharmaceutique société à mission.
**_Qui nous recherchons_**
**Position in Late Phase Unit - Global Clinical Operations**
The **Late Phase Clinical Operations Lead** is responsible for the overall coordination and management of clinical trials (phase II to IV), from their creation to the final delivery. He/She will be at the forefront of innovation and be expected to drive using his/her project leadership and operational excellence.
**Principales responsabilités**
- 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)
- Supervises the clinical operations of one or more programs, including the management of the overall budget (forecasting and maintenance)
- Supervises one or more Clinical Project Managers (CPMs) involved in different trials
- Supports the 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 CPM during study design and protocol 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)
- Line Management of Late Phase Clinical Project Managers
**Expérience requise**
- 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.
- Previous significative experience in the management of international clinical trial projects
**Formation**
- Scientific background (Degree in Life Sciences (biological science, pharmacy or other health related discipline) or equivalent)
**Langues**
- Proficient in oral and written English
**Compétences techniques**
**Compétences comportementales**
- Capacité d'analyse
- Compétences en communication
- Compétences en planification et en organisation
- Gestion des conflits
- Gestion du temps
- Leadership et influence sociale
- Orientation vers la qualité
- Prise de décision
- Réflexion stratégique
- Proactivité
- Résolution de problème
- Travail d’équipe
- Orientation vers les objectifs
CHIESI SAS est un laboratoire familial, qui s’engage au quotidien de manière responsable, aussi bien auprès de ses partenaires internes qu’externes, afin de promouvoir la diversité et l’égalité des chances pour tous.
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