Outsourcing Manager

il y a 3 jours

BoulogneBillancourt, France Ipsen Innovation (SAS) Temps plein

**Monitor in-vitro and in-vivo non-GLP and GLP safety pharmacology and toxicology studies (from Lead selection to registration)**
- Participate to the selection of appropriate CROs for a given study
- Schedule and design the study protocols, ensure appropriate initiation of the study and adequacy of the protocol with the project needs, under the supervision of the NCDS project manager
- Supervise critical phases of the study, including regular on-site visit at CROs
- Review on-line study data to ensure appropriate adaptation of the study protocol
- Review content of the different draft reports, liaise with the NCDS project manager to deliver a final draft for approval by NCDS management

**Support NCDS regulatory documentation**
- Responsible for the quality and adequacy of the tabular and written toxicology summaries for submission (review of TSR received from the CRO, update or review of regulatory documents (IB, IND, Briefing documents)
- Responsible for delivery of RFS documents (study reports and regulatory summaries) in the Ipsen document management system
- Responsible for ensuring study data compliant and for loading in the Ipsen data base
- Responsible for ensuring that the SEND data format request is contracted to service providers, communication with Non Clinical Data Manager to ensure good quality of SEND data and that deadlines are respected.
- Support for project managers according to the problematic encountered (bibliographical research, Review/QC of documents )

**Manage Outsourcing**
- Set up a process for search, evaluation, and selection of contract organization (CRO) to support NCDS activities
- Maintain and update a database including CRO features

**Be the LRM (Local Resources Manager) for NCDS**
- Create and update NCDS Function plans for all the projects (Creation/update of dates, cost, FTE per task for studies, support to regulatory activities, support to program/project)
- Discussions with NCDS Project Managers and regular meetings with DMPK to align the DMPK and NCDS plans

EHS responsibilities:

- Comply with applicable EHS regulations and procedures.
- Participate in the site's EHS performance by reporting risks, malfunctions or improvements

Participate in mandatory EHS training

LI-MC1

**#LI-Hybrid

  • Outsourcing Manager

    il y a 1 semaine

    Boulogne-Billancourt, France Excelya Temps plein

    **About the Job** Join Excelya, where **Audacity, Care, and Energy** define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand. This role is an exciting opportunity to contribute to a dynamic, ambitious team in Clinical Operations. You will play...

  • Gestionnaire Expert Contrats Cotisations

    il y a 1 semaine

    Boulogne-Billancourt, France Cegedim Temps plein

    Notre Direction Business Process Outsourcing recrute un(e)Gestionnaire Expert Contrats Cotisations. Aux côtés d'un manager engagé et bénéficiant d'une expertise reconnue,vous interviendrez sur des problématiques de cotisation, d'adhésion et d'analyse vous permettant d'enrichir vos connaissances et compétences dans notre domaine. Nous souhaitons par...

  • Gestionnaire Recouvrement

    il y a 1 semaine

    Boulogne-Billancourt, France Cegedim Temps plein

    Pour faire face à ses enjeux business et d'amélioration de notre service Recouvrement,notre Direction BPO (business process outsourcing) recrute un gestionnaire (H/F) en CDD pour un remplacement de congé parental. Aux côtés d'un manager engagé et bénéficiant d'une expertise reconnue, vous aurez la responsabilité du traitement des litiges tout en...

  • Cloud Infrastructure

    il y a 2 semaines

    Boulogne-Billancourt, France Ipsen Pharma (SAS) Temps plein

    Ipsen is a dynamic and 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** and providing them with effective therapeutic solutions for unmet medical needs through differentiated and innovative...

  • Senior Account Manager

    il y a 2 semaines

    Boulogne-Billancourt, Île-de-France Sidetrade Temps plein

    About Sidetrade ) Sidetrade is a SaaS company, listed on Euronext Growth, on a mission to revolutionize the way large enterprises unlock value from their customers leveraging its AI-powered Order-to-Cash solutions. Positioned as a Gartner Magic Quadrant Leader since 2022, with a strong growth trajectory across North America and Europe, we're proud of our...

  • Senior Account Manager

    il y a 2 semaines

    Boulogne-Billancourt, Île-de-France Sidetrade Temps plein

    About Sidetrade )Sidetrade is a SaaS company, listed on Euronext Growth, on a mission to revolutionize the way large enterprises unlock value from their customers leveraging its AI-powered Order-to-Cash solutions. Positioned as a Gartner Magic Quadrant Leader since 2022, with a strong growth trajectory across North America and Europe, we're proud of our...

  • Global Procurement Business Partner

    il y a 6 jours

    Boulogne-Billancourt, France Ipsen Pharma (SAS) Temps plein

    Come join a team of Procurement professionals who specialize in driving value and partnering with the business in a dynamic Biopharmaceutical company. If GROWTH supporting a robust clinical pipeline as part of a Global Procurement organization gets you excited Then, look no further! **Position Overview** As the Global Procurement Business Partner,...

  • Manager, Clinical Partnerships Oversight

    il y a 2 semaines

    Boulogne-Billancourt, France Ipsen Pharma (SAS) Temps plein

    **Purpose of the position** The Clinical Partnerships Oversight Manager is responsible for supporting the management of Ipsen’s relationships with it’s Service Providers (CROs) within Clinical Development. They are a critical player in the Service Provider Governance and Escalation structure, working to support the Clinical Partnerships Oversight...

  • Global Category Buyer Rare Diseases

    il y a 6 jours

    Boulogne-Billancourt, France Ipsen Pharma (SAS) Temps plein

    **Summary / purpose of the position** The Global Category Buyer, Clinical and Medical will be responsible for a multi-million clinical trials spend related to Clinical and Medical Services (Clinical Full Services Outsourcing & Functional Service Provision such as Data Management, Biostatistics, Medical Imaging, Medical Writing, Electronic Data Capture, IRT,...

  • Analyste Développeur Talend H/F

    il y a 2 semaines

    Boulogne-Billancourt, France Cegedim Temps plein

    Fondé en 1969, Cegedim est un Groupe innovant de technologies et de services spécialisé dans la gestion des flux numériques de l’écosystème santé et BtoB, ainsi que dans la conception de logiciels métier destinés aux professionnels de santé et de l’assurance. Cegedim compte près de 6 700 collaborateurs dans plus de 10 pays et a réalisé un...