Rgulatory and Start Up Specialist

Il y a 6 mois

Paris, France Novasyte Temps plein

Job Overview

Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.
_French and English Fluent._

Essential Functions
- Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.
- Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.
- Prepare site regulatory documents, reviewing for completeness and accuracy.
- Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
- Review and provide feedback to management on site performance metrics.
- Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
- Inform team members of completion of regulatory and contractual documents for individual sites.
- Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
- Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
- Perform quality control of documents provided by sites.
- May have direct contact with sponsors on specific initiatives.

**Qualifications**:
Bachelor’s Degree in life sciences or a related field and 3 years’ clinical research or other relevant experience; or equivalent combination of education, training and experience.
- In-depth knowledge of clinical systems, procedures, and corporate standards.
- Knowledge of applicable regulatory requirements, including local regulations,, SOPs and company’s Corporate Standards.
- Understanding of regulated clinical trial environment and knowledge of drug development process.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at

  • Local Start-up Specialist, Fra

    Il y a 5 mois

    Paris, France Allucent Temps plein

    The Local Start-up Specialist (LSUS) coordinates and performs local site start-up activities of Allucent Study Start-up & Site Intelligence. This position executes essential document collection, Regulatory Authority (RA) and Independent Ethics Committee (IEC)/Institutional Review Board (IRB) submission/approval activities. The LSUS may also perform site...

  • Study Start Up Specialist

    Il y a 6 mois

    Paris, France TFS HealthScience Temps plein

    Overview: TFS HealthScience is excited to be expanding our **Study Start Up **team and we are looking for an experienced, highly motivated **Study Start Up Specialist (SSU Sp)** who shares our vision of providing clinical research excellence. Our **Study Start Up **team is a highly experienced international group of professionals led by an industry...

  • Regulatory & Start Up Specialist, French Speaker

    Il y a 6 mois

    Paris, France Novasyte Temps plein

    IQVIA MedTech Clinical Solutions, specializes in clinical research for Medical Devices and In-Vitro Diagnostic (IVD) products.- IQVIA MedTech’s focused expertise meets the growing needs of device Sponsors to justify product safety and effectiveness as well as reimbursement and adoption challenges due to increased scrutiny by regulators, end-users, and...

  • Regulatory and Start Up Specialist

    Il y a 6 mois

    Paris, France Novasyte Temps plein

    Job Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Essential Functions - Under general supervision, serve...

  • Start Up Assistant

    Il y a 6 mois

    Paris, France ICON plc Temps plein

    Start Up Assistant At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability &...

  • Momentum (Start-up) - CEO

    Il y a 3 mois

    Paris, France EMERTON GROUP Temps plein

    KAUKANA VENTURES Kaukana Ventures is a **start-up studio** with deep expertise in AI and Data Science that focuses on four major areas : AI, Agriculture, Future of Work and FinTech Web3. We anchor our studio on very robust technology foundations. Kaukana Venture incubates and ramps-up new ventures and products on promising topics. Our best-in-class...

  • Study Start Up Associate Ii

    Il y a 2 mois

    Paris, France Icon plc Temps plein

    Study Start Up Associate - France - Office or Home based ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development Study Start Up Associate II At ICON,...

  • Study Start Up Associate

    Il y a 5 mois

    Paris, France ICON plc Temps plein

    Study Start Up Associate At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation:...

  • Regulatory and Start-up Manager

    Il y a 6 mois

    Paris, France Novasyte Temps plein

    Job Overview Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources. Essential Functions - Oversee the execution of Site Activation (including pre-award/bid defense activities)...

  • Business Development Manager for Start-Up Partnerships

    il y a 4 semaines

    Paris, Île-de-France Dell Technologies Temps plein

    Transform Your Career as an Account Executive, Gen AI for Start-UpsDell Technologies' Direct Sales team is seeking a highly skilled Account Executive to join our team in Paris. As a key player in driving expansion across existing accounts and developing brand new opportunities, you will be responsible for building strong customer relationships and ensuring...

  • Cabinet d’avocat start-up à Paris

    il y a 6 jours

    Paris, France Breizhpower Temps plein

    Lancer sa start up n’est pas une mince affaire. Des compétences dans le domaine juridique, fiscal et entrepreneurial sont nécessaires à la viabilité de votre projet. Par bonheur, Akheos Lab met à votre disposition son équipe d’avocats pour vous permettre d’engager sereinement votre entrée dans le monde entrepreneurial. Akheos Lab, une équipe de...

  • Cabinet d’avocat start-up à Paris

    il y a 1 jour

    Paris, France Breizhpower Temps plein

    Lancer sa start up n’est pas une mince affaire. Des compétences dans le domaine juridique, fiscal et entrepreneurial sont nécessaires à la viabilité de votre projet. Par bonheur, Akheos Lab met à votre disposition son équipe d’avocats pour vous permettre d’engager sereinement votre entrée dans le monde entrepreneurial.Akheos Lab, une équipe de...

  • Start-up Supervisor

    il y a 9 heures

    Paris, France Menzies Aviation Temps plein

    **Overview** People. Passion. Pride. This is what has driven our teams since 1833. Since that time, we have developed to become a critical partner in the global aviation industry, delivering time-critical logistics services at over 290 locations in 65 countries, across 6 continents. But at the heart of our business is our people. **Role Purpose** As...

  • Business Development Manager

    Il y a 3 mois

    Paris, France annoncesAtlas Temps plein

    **Role Snapshot**: As a work-study Business Developer at NBS Factory, you'll help expand our market presence, support sales strategies by actively seeking out customers, follow up and maintain customer relationships. This role combines sales, marketing and analytical skills, focusing on promoting our AI-based ESG solutions. **Main Missions**: - **Brand...

  • Spécialiste en Marketing Digital pour Start-up Mobile

    il y a 2 semaines

    Paris, Île-de-France L'ÉCOLE FRANÇAISE Temps plein

    Découvrez notre opportunité d'alternanceL'Ecole Française, experte en éducation numérique, s'associe à une start-up innovante dans le secteur des applications mobiles, basée à Paris. Nous proposons un contrat d'apprentissage unique permettant de préparer son Bachelor Marketing et Communication en alternance.Compétences requisesExpertise en...

  • Responsable de Ventes pour Start-up Technologique

    il y a 3 semaines

    Paris, Île-de-France UPTOO Temps plein

    Professionnel Expérimenté Souhaité pour une Équipe DynamiqueNous sommes à la recherche d'un professionnel expérimenté pour rejoindre notre équipe de vente comme Responsable de Ventes pour une start-up technologique innovante.

  • Responsable Commercial Start-up

    Il y a 2 mois

    Paris, France Talents Locaux Temps plein

    Notre client est une jeune start-up de 10 personnes qui va débuter prochainement la commercialisation de ses services. Leur solution est un produit financier aux producteurs agricoles comme aux acheteurs de moins subir les fluctuations des prix. Vous serez le premier commercial de l'équipe et serez directement rattaché à l'un des deux associés...

  • Spécialiste en Communication Digitale

    il y a 4 semaines

    Paris, Île-de-France Invest in start-up Temps plein

    MissionEn tant que Spécialiste en Communication Digitale, vous rejoindrez l'équipe d'Invest in start-up pour renforcer notre présence en ligne. Votre mission consiste à développer et à animer nos comptes sur les réseaux sociaux, à créer du contenu attractif et à suivre les tendances du secteur pour adapter notre stratégie de...

  • Data Scientist @ start-up

    il y a 3 semaines

    Paris, France Up Systemhaus Temps plein

    Licorne Society met en relation les talents avec plus de 3000 startups en France, couvrant tous les secteurs et métiers. Que les startups soient en création ou en phase d'hypercroissance, toutes cherchent des profils audacieux sur Licorne Society. Licorne Society vise à faire matcher les candidats avec les meilleures opportunités disponibles.In this role...

  • Business Developer en Start-up

    Il y a 5 mois

    Paris, France SalesLink Temps plein

    Qui sommes nous ? SalesLink est la plateforme qui met en relation des start-ups avec des commerciaux top performers. Notre mission ? Repérer les meilleurs profils et trouver la mission dans laquelle ils vont s'épanouir (professionnellement et financièrement) Une fois ton inscription validée sur notre plateforme, ton profil est accessible à nos...