Opportunité d’Emploi : Clinical Operational Data Steward Leader chez Sanofi

Emploi à Budapest, Hongrie

Titre du poste : Clinical Operational Data Steward Leader
Entreprise : Sanofi
Localisation : Budapest, Hongrie
Type de contrat : Permanent, temps plein, mode hybride

Aperçu du poste

*Êtes-vous prêt à façonner l’avenir de la médecine ?* Chez Sanofi, la priorité est de résoudre rapidement les défis en matière de découverte de médicaments et de développement, contribuant ainsi à améliorer la vie des patients et de leurs familles. En rejoignant notre équipe de Data Intelligence for Clinical Operations (DICO), vous jouerez un rôle clé dans la stratégie et la coordination de la gouvernance des données opérationnelles cliniques.

Responsabilités principales

1. Liaison avec les équipes d’étude :

• Agir en tant que contact principal stratégique pour les utilisateurs finaux, en répondant à leurs questions et en coordonnant la gestion des demandes liées aux données opérationnelles.
• Assurer la coordination des groupes transversaux pour prendre des décisions rapides et livrer des livrables opérationnels communs.
• Mettre en œuvre des solutions efficaces pour garantir la qualité et la cohérence des données, en réalisant des analyses d’impact.

2. Fondations des données opérationnelles cliniques :

• Conduire la normalisation des données opérationnelles, en développant des définitions harmonisées et en supervisant la création de référence dans les systèmes.
• Recommander des optimisations des flux de données, en tirant parti des technologies numériques pour améliorer la qualité.
• Définir et coordonner le suivi des processus de gouvernance des données pour garantir leur conformité.

3. Formation et communication :

• Soutenir le responsable DICO dans les activités de gestion du changement, à travers la documentation de communication et des formations sur les actifs de données opérationnelles.
• Organiser des communications régulières sur les évolutions des données et les meilleures pratiques.

Profil recherché

Expérience :

• Minimum 5 ans dans le développement clinique, avec une expérience significative en gestion d’études cliniques.

Compétences interpersonnelles :

• Excellentes compétences en communication et en collaboration, avec une grande capacité à travailler dans un environnement matriciel.
• Orienté résultats, autonome et engagé.

Compétences techniques :

• Compréhension approfondie des processus de gestion des données dans le développement clinique.
• Expérience avec les systèmes de gestion des données cliniques.
• Intérêt pour les évolutions techniques et une connaissance actuelle des systèmes de gouvernance cliniques.

Formation :

• PharmD ou Master dans un domaine scientifique et/ou médical pertinent.

Pourquoi rejoindre Sanofi ?

• Collaborer avec une équipe internationale et axée sur l’avenir dans un environnement de travail innovant.
• Bénéficier d’une politique de télétravail flexible et d’un environnement de bureau primé en 2023.
• Profiter d’un package de rémunération attractif et d’avantages liés à la santé et au bien-être.
• Débuter avec un parcours d’intégration structuré et un mentor pour vous accompagner.
• Faire partie d’une communauté dynamique avec des événements réguliers tels que des soirées jeux et des clubs de sport.

Engagement de diversité et inclusion

Sanofi s’engage à offrir des opportunités égales à tous, indépendamment de toute caractéristique individuelle. Cette politique inclut la mise en œuvre d’actions pour promouvoir la diversité au sein de l’entreprise.

Salaire attendu : À discuter lors du processus de sélection
Date du poste : Ouvert depuis le 3 juin 2025

Postulez dès maintenant !

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📅 Date de publication de l’offre : Tue, 03 Jun 2025 22:16:54 GMT

🏢 Entreprise : Sanofi

📍 Lieu : Budapest

💼 Intitulé du poste : Clinical Operational Data Steward Leader

💶 Rémunération proposée :

📝 Description du poste :

• Job title: Operational Data Steward Leader
• Location: Budapest, Hungary
• Job type: Permanent, full-time
• Hybrid working

About the jobAre you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?Join our global Data Intelligence for Clinical Operations (DICO) team as an Operational Data Steward Leader and you’ll be accountable for the strategy and coordination of the E2E governance of clinical operational data: study design characteristics, study stakeholders (study team members, vendors, investigational sites, HCPs…), study milestones and status, study recruitment data. You’ll also present this strategy to Top Management via the DICO Steering Committee.Main responsibilities:1. Liaise with study teams – Study support for operational data

• Serve as Strategic primary contact for end-users within Clinical Operations answering to any questions, requests from other functions. Coordinate the requests review management of study-specific operational data at study level and / or updates in dictionaries in master data systems, based on customer needs. Understand business needs of study end-users, define or update operational data and associated process and quality rules.

• Coordination of transversal groups to manage Use Cases to align operational players for agile/fast decision making and delivery of common operational deliverables. Ensure cross-functional vetting and awareness of implementation activities across Therapeutic Areas.

• Lead the implementation of the effective solution in addressing quality and consistency measures depending on data criticality, including definition harmonization, investigations and impact analysis for functions using these data.

2. Clinical Operations Data Foundations

• Lead the management of Operational Data Standardization (definition, dictionaries, data flow to consuming systems…) in using common vocabulary for a same concept used by several functions. Supervise the reference data development and cleaning in a harmonized way in systems.

• Drive policy-related actions: Streamline processes and associated quality documents (global SOPs, policies, guidelines…) that describe the management of the operational data and implement new working practices. Define the level of control based on data criticality (ex: Reg transparency… vs internal).

• Recommend data flow optimization, capitalizing on electronic tools, to address new requests and assess their impacts to shorten the cycle time and improve overall quality. Manage regular analysis of information reported from a broad variety of sources. Lead the digital transformation to implement an automatic process (AI, ML, NLP…) linked to the operational data to propose data related evolutions.

• Define and coordinate the monitoring of data governance processes adherence to target model and good use of data in clinical trials managed by Clinical operations (KPI or data quality metrics and deviations from acceptable levels).

3. Train and communicateSupport the DICO Head in change management activities to drive a data-driven R&D organization:

• Drive supporting documents for communication, education and trainings related to Operational Data assets

• Organize communications on updates or evolutions, users feedback, exchange of best practices and lessons learned. Promote operational data activities (including new usages)

About youExperience:

• At least 5 years in Clinical Development with background in clinical study management. Background or great interest in databases management.

Soft Skills:

• Good communication skills and ability to facilitate common understanding of people with various backgrounds, collaborative spirit

• Strong organizational skills, efficiency in matrix organization. Ability to effectively handle multiple tasks and to prioritize, results oriented

• High level of autonomy and commitment

• Customers & quality focused. Ability to simplify complex processes in developing guidelines and tools

• Flexible and Open-minded, Eager to learn with interest and ability to understand new perimeters

• Problem-solving and decision-making capabilities, with analytical and synthetic spirit.

• Project management skills: able to monitor a process, and lead to progress and results. Ability to anticipate, timely escalate issues and define appropriate action plans.

• Good Knowledge and familiarity with industry standards and practices, clinical development process, international regulatory guidelines and GCP requirements

• Good English Communication level (written and oral)

Technical skills:

• Excellent transversal understanding of the Data Flow and Data Management processes in Clinical Development.

• Experienced with clinical data management systems and has a sound understanding of database and programming concepts, database structures, file structures (CTMS and satellites, planning tools…)

• Interest for technical evolutions – Digital-oriented. Up to date knowledge on clinical governance systems such as MDM, Data Catalog and data mapping solutions

Education:PharmD or Master’s degree in relevant scientific and/or medical fieldLanguage(s):

• Strong English skills (verbal and written), ability to exchange fluently in a global environment

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team in an international work environment
• Work from an « Office of the Year 2023 » award winner with flexible home office policy
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave
• An individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeks
• Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs)

Pursue Progress. Discover Extraordinary.Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.Watch our and check out our Diversity Equity and Inclusion actions at !Discover our , that serves as the moral compass that guides us when chasing the miracles of science to improve people’s lives. Please ensure to have read this document before applying.#Sanofi #SanofiCareers #joinSanofi#jobopportunities #careeropportunities #sscjob#Sanofi_Budapest_Hub #Budapest#R&D#LI-EUR #LI-hybridPursue progress, discover extraordinaryBetter is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.Watch our and check out our Diversity Equity and Inclusion actions at !

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