ALSI - RWE & Clinical operations Director H/F

Company:  Balazs
Location: Bagneux
Closing Date: 01/12/2024
Salary: £80 - £100 Per Annum
Type: Temporary
Job Requirements / Description
ALSI - RWE & Clinical Operations Director H/F Locations: France, Bagneux Time Type: Full Time Posted on: Posted Yesterday Descriptif de l'entité et de l'activité Avec près de 16 500 collaborateurs, une présence dans 35 pays, un chiffre d’affaires de plus de 3,5 milliards d’euros, Air Liquide Healthcare, la branche Santé du Groupe Air Liquide, est un des leaders mondiaux dans ce domaine. Aujourd’hui, Air Liquide Healthcare est présent à l’hôpital et au domicile des patients pour y fournir des produits, des services et des programmes d’accompagnement pour la prévention, le diagnostic et le traitement de maladies chroniques ou lors d’épisodes aigus. Quelle sera votre contribution et comment vous épanouir dans ce poste ? Reporting to the Vice President Evidence & Access, the RWE & Clinical Operations Director will contribute to the achievement of the company’s objectives by planning, designing & executing RWE studies and clinical trials, ensuring adherence to regulatory guidelines while optimizing operational effectiveness and shaping the future of evidence generation. The RWE & Clinical Operations Director will be a permanent member of the future Evidence Design committee and will closely collaborate with the HEOR lead as well as with Biometry, Medical Affairs, and Market Access to streamline interactions and responsibilities regarding global evidence generation. Responsibilities: RWE studies & clinical trials planning, design and execution As a member of the Evidence Design committee, propose strategic and pragmatic solutions to answer business needs. Manage and oversee RWE studies and clinical trials across therapies. Set up and roll out the clinical studies governance. Set up a process to monitor global activities in clinical research. Advise and support countries in developing study protocols and execution. Operational excellence Drive operational efficiency & streamline processes. Optimize collaboration with external partners. Manage studies budget and targets. Train and support end-users. Quality, regulatory and compliance Embed a study vetting and approval process to safeguard quality. Ensure scientific rigor and regulatory compliance for all research activities. Advise and support countries in the best regulatory approaches. Support quality management activities. VBHC transformation and smart evidence generation Maintain and develop relevant relationships with key institutions and research groups. Engage with regulatory bodies and health agencies. Support outcomes collection and research activities for efficient RWE generation. Contribute with the E&A team to further develop a smart evidence generation roadmap. The RWE & Clinical Operations Director will lead a team of two clinical project managers and one regulatory & compliance lead and will be responsible to: Provide guidance to the team in their day-to-day activities. Maintain and develop the team's expertise. Engage and coach people to success. Drive and sustain a culture of performance. Etes-vous LA personne faite pour ce poste ? At least 8-10 years work experience in healthcare/Life science in a managing position. Strong knowledge of the drug and medical device pharmaceutical industry and its corresponding regulations. Ability to interpret and apply understanding of the regulators’ thinking to projects. Excellent understanding of RWE and secondary use of data challenges and opportunities. Demonstrated skills in the successful design and execution of RWE studies and clinical trials. Demonstrated ability to lead team members in conveying evidence of value. Demonstrated ability to set and execute on priorities and manage multiple projects. Ability to continuously adapt in a rapidly changing atmosphere. Outstanding leadership and interpersonal skills. Excellent oral and written communication skills in English. Nos différences font notre performance Chez Air Liquide, nous nous engageons à créer un environnement de travail collaboratif et inclusif. About Us A world leader in gases, technologies and services for Industry and Health. Through the passion and diversity of its people, Air Liquide leverages energy and environment transition, changes in healthcare and digitization. Join us for a stimulating experience: you’ll find a world of learning and development opportunities. Discover what your professional journey at Air Liquide could be here! #J-18808-Ljbffr
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