Clinical Project ManagerIPSEN

Ipsen est un groupe biopharmaceutique mondial de taille moyenne, spécialisé dans les médicaments transformateurs dans trois aires thérapeutiques : l'oncologie, les maladies rares et les neurosciences. Forts de près de 100 ans d'expérience en développement, avec des Hubs mondiaux aux États-Unis, en France et au Royaume-Uni, nous focalisons nos efforts là où les besoins médicaux non satisfaits sont importants, grâce à la recherche et à l'innovation.

Nos équipes passionnées, présentes dans plus de 40 pays, se concentrent sur l'essentiel et s'efforcent chaque jour d'apporter des médicaments aux patients dans 88 pays. Nous construisons un environnement de travail qui met en avant un leadership centré sur l'humain et favorise une culture de collaboration, d'excellence et d'impact. Au sein d'Ipsen, chaque individu est encouragé à être soi-même, à grandir et à s'épanouir aux côtés du succès de l'entreprise. Rejoignez-nous dans notre démarche vers une croissance durable, en créant un impact réel sur les patients et la société.

Pour plus d'informations, visitez notre site web à l'adresse https://www.ipsen.com et suivez nos dernières actualités sur LinkedIn et Instagram.

Are you ready to lead and innovate in a dynamic, patient-focused biopharmaceutical company?

Ipsen is a growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients' health and quality of life, providing effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences, and Rare Diseases.

Why Ipsen?

• Patient-Focused: The patient is at the heart of everything we do, and improving their outcomes is the deliverable of every strategy.

• Employee Care: We care for our employees, who are the ambassadors making a real difference.

• Bold Leadership: We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions.

• Growth Opportunities: We offer a wealth of fulfilling challenges and growth opportunities in a fast-moving, game-changing organization.

About the Role

The Clinical Project Manager (CPM) is a Project Leader with the end to end accountability for the successful execution of global Evidence Generation activities.

Main Responsibilities

• Planning, initiating, conducting and reporting for all assigned evidence generation projects
• Where activities are outsourced this means oversight of the Service Provider (SP) and co-ordination of internal cross functional team (CFT), if in house then this is undertaking the activities personally and coordinating the deliverables of the internal CFT.
• Responsible for activities/task packages delegated to you for projects assigned and/or take accountable for own projects (smaller and/or less complex projects).

Preparation of the study

• Set-up and lead the study Cross Functional Team (CFT) overseeing study design and kick-off activities. - Initiate high level feasibility and continuously monitor how changes to the study design affect feasibility during the preparation and development of the study protocol.

Initiation of the study

• Lead the SP selection process (RFP creation, bid defense, contracting) and in collaboration with the CFT, Global Procurement and Corporate Legal Affairs.
• Co-ordinate completion of the study Integrated Oversight Plan (IOP) prior to initiation of the study defining and agreeing KPIs/QTLs/Performance indicators with SPs and the Cross Functional Team.
• Oversee SP performance and creation of documents required for the execution of the study

Study Conduct

• Coordinate the CFT (internal and SPs) overseeing the progress of the study and SP's performance to ensure timely on budget delivery.
• Monitor execution and delivery of KPIs/QTLs/Performance indicators as agreed in the IOP.
• Provide and present regular reports on study progress including site performance, data quality and resource needs.

Study Completion

• Coordinate the preparation, the review and the submission of the CSR with Medical Writing.
• Ensure the finalization and archiving of the eTMF.

Qualifications

• Bachelor's life science degree or Master's degree or equivalent
• Experience in pharmaceutical drug development (Ph2, Ph3)
• Experience in project management of national and international programs
• Relevant experience in RWE/HEOR, NIS studies
• Experience and know-how in Oncology or in Rare Diseases or in Neurosciences
• Proven track record of delivery of projects to time, budget and quality.
• Strong knowledge of Good Clinical Practice (GCP)
• Experience of managing and developing relationships with Service Providers
• English fluency
• Computer literacy
• Ability to travel as required with the needs of the role, up to approximately 25% of the time.

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