![EXCELYA](https://media.trabajo.org/img/noimg.jpg)
Clinical Project Manager
il y a 3 jours
Créée en 2014, Excelya est une organisation de recherche sous contrat (CRO) « people centered ».
Nous proposons une expérience personnelle et authentique au sein d'une jeune entreprise de santé ambitieuse en passe de devenir le leader de la recherche clinique en Europe grâce à nos 800 Excelyates. Nous nous engageons à donner à chaque Excelyate les moyens d'exprimer ses talents naturels, de développer son plein potentiel et de s'investir dans notre projet unique.
Pour en savoir plus sur nous, visitez www.excelya.com
Activités :
Dans le cadre de cette mission, le prestataire peut être amené à assister les Attachés de Recherche Clinique, le data Manager, et le manager des affaires cliniques.
Gestion globale des essais cliniques
- Documents de l’étude (protocole et rapports)
- Gestion opérationnelle des études de la sélection à la clôture (donner une orientation aux équipes, contribuer aux procédures de sélection des patients, gestion du monitoring et des dispositifs, suivi des données cliniques et de sécurité)
- Réunion et Compte-rendu du suivi de l’étude (données, monitoring, incidents, recommandations et solutions aux problèmes identifiés…)
- Documentation de la qualité de l’étude
Gestion règlementaire des essais cliniques
- Soumission règlementaire : obtention des autorisations des autorités compétentes et comités de protection des personnes
- Préparation de documents spécifiques selon le pays et/ou les centres d’investigation clinique Tracking et Metrics (versions, approbations…)
- Responsable du contenu du « Trial Master File »
- Référent pour les audits/inspections menés sur les études cliniques supervisées Etablissement et suivi du budget des centres
Etablissement et suivi du budget des centres
- Etablissement des contrats et suivi du budget
- Procédure / Fichier Excel
Gestion des CRO / Partners
- Formations, suivi et supervision des activités hebdomadaires / reporting
- Gestion du budget
Profil recherché :
Les compétences attendues pour la réalisation des travaux sont de type « Chef de Projet clinique » avec un niveau « confirmé ».
Les critères qualitatifs d’évaluation des offres de services sont les suivants :
- Excellentes capacités de planification, d'organisation et de résolution de problèmes
- Excellentes compétences en communication verbale, écrite et en présentation en Anglais
- Bonnes capacités d'analyse et de négociation, et de synthèse
- Capacités de leadership
- Etre rigoureux et proactif, et force de proposition
- Connaissances approfondies en matière de recherche clinique et dispositifs médicaux : ISO 14155, réglementation européenne des DM 2017/745, FDA CFR Part 812 et Part 814
- Efficacité à travailler de manière autonome au sein d'une équipe clinique.
- Anglais courant
- Formation scientifique ou qualité
- Connaissance en cardiologie et chirurgie cardiaque, sera appréciée
- Expérience dans une fonction de chef de projet d’au moins 4 ans
-
Clinical Operation Lead
il y a 3 jours
Île-de-France Excelya Temps pleinI-ExcelyaCreated in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model - leveraging...
-
Clinical Operation Lead
il y a 4 jours
Île-de-France, France Excelya Temps pleinI-ExcelyaCreated in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model - leveraging...
-
Clinical Monitoring Lead
il y a 3 jours
France Excelya Temps pleinCreated in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 900 Excelyates. Our unique one-stop provider service model – leveraging full-service,...
-
Clinical Monitoring Lead
il y a 3 jours
France, FR Excelya Temps pleinCreated in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 900 Excelyates. Our unique one-stop provider service model – leveraging full-service,...
-
Project Manager
il y a 1 semaine
Paris, Île-de-France Saipem - GPS Temps pleinMission • Ensure the governance of projects and initiatives in terms of organizational, financial, technological and contractual aspects, assuring the achievement of the established objectives • Plan, coordinate and control the execution of the project, in accordance with the Client requirements, within time and cost constrains and in compliance...
-
Clinical Research Associate
il y a 4 jours
France, FR OPIS Temps pleinAs a Clinical Research Associate (CRA) you are an essential part of the clinical operations team responsible for coordinating and overseeing the execution of studies and clinical trial according to the study protocol, ICH-GCP, applicable regulations, guidelines and sponsor requirements.Some of what you will do:Identify investigator sites and participate in...
-
Energy Storage Project Manager
il y a 3 jours
Île-de-France borea Temps pleinYou will undertake some of the responsibilities, tasks and duties listed below:Lead and manage storage or hybrid projects with merchant and contracted revenue streams, potentially in collaboration with local entities, while ensuring adherence to project scope, timelines, and budget.Collaborate with all internal stakeholders including financial, dispatch...
-
Energy Storage Project Manager
il y a 4 jours
Île-de-France, France borea Temps pleinYou will undertake some of the responsibilities, tasks and duties listed below:Lead and manage storage or hybrid projects with merchant and contracted revenue streams, potentially in collaboration with local entities, while ensuring adherence to project scope, timelines, and budget.Collaborate with all internal stakeholders including financial, dispatch...
-
Project Management Officer H/F
il y a 24 heures
Île-de-France, France Axian Group Temps pleinAXIAN GROUPCluster Telecom Project Management Officer M/FLocation: Antananarivo - MADAGASCARAxian is a pan-African group that operates in 5 sectors of activity with high growth potential: real estate, telecommunications, financial services, energy and innovation. Axian is present in 9 countries in the Indian Ocean and the African continent and acts as a...
-
Clinical Applications Specialist
il y a 4 semaines
Paris, Ile-de-France, France Hologic Temps pleinClinical Application Specialist - SurgicalLocation: Paris or LyonPosition Overview: We are seeking a dedicated and experienced Clinical Application Specialist to join our dynamic team. The successful candidate will be responsible for providing clinical expertise, support, and training to customers in our surgical product area. You will play a critical role...
-
Clinical Applications Specialist
il y a 3 semaines
Paris, Ile-de-France, France Hologic Temps pleinClinical Application Specialist - Surgical (12 month Fixed Term Contract)Location: Paris or Lyon Position Overview: We are seeking a dedicated and experienced Clinical Application Specialist to join our dynamic team. The successful candidate will be responsible for providing clinical expertise, support, and training to customers in our surgical product...
-
Clinical Research Associate
il y a 3 jours
France Meet Temps pleinWelcoming All Clinical Research Associates!!!!Our client, a leading healthcare intelligence and clinical research organization, is seeking an experienced Clinical Research Associate (CRA) to join their team.With a focus on advancing clinical research from molecule to medicine, they provide outsourced services to various sectors within the healthcare...
-
Clinical Research Associate
il y a 4 jours
France, FR Meet Temps pleinWelcoming All Clinical Research Associates!!!!Our client, a leading healthcare intelligence and clinical research organization, is seeking an experienced Clinical Research Associate (CRA) to join their team.With a focus on advancing clinical research from molecule to medicine, they provide outsourced services to various sectors within the healthcare...
-
Product Manager/Project Manager Data/IA
il y a 6 jours
Île-de-France VISIAN Travail à distance Freelance Temps pleinDans le cadre de ses projets clients, Visian est à la recherche d'un Product Manager/Project Manager Data/IAPrincipales Missions :- Mise en place et suivi de la gouvernance des donnés- Définition et mise en place de KPI de suivi de la productivité des développeurs / projets (avec les BLIs)- Suivi, collecte et consolidation globale de ses KPIs pour...
-
Technical Project Manager
il y a 3 jours
Île-de-France Stott and May Temps pleinTechnical Project Manager Needed for Exciting Restaurant Chain Conversion!Initial 6 month contractCompetitive Day Rate €Are you a seasoned Technical Project Manager with a strong background in retail or hospitality? Do you thrive on managing complex projects and working closely with third-party vendors? If so, we have an incredible opportunity for...
-
Technical Project Manager
il y a 4 jours
Île-de-France, France Stott and May Temps pleinTechnical Project Manager Needed for Exciting Restaurant Chain Conversion!Initial 6 month contractCompetitive Day Rate €Are you a seasoned Technical Project Manager with a strong background in retail or hospitality? Do you thrive on managing complex projects and working closely with third-party vendors? If so, we have an incredible opportunity for...
-
Project Control Manager Offshore Oil and GasH/F
il y a 3 jours
Île-de-France MPH Temps pleinMissions: o all contracts (EPCs, Licensing, long term lease agreements, contracts for Field Operations…). Overall value well above the CAPEX value of the Project.o the overall budget (LOP/Annual and OPEX)o the cost controlo Planning and reportingo Relations with the authorities and our partnerso Risk managemento Doc Controlo IT / offices / logistics and...
-
Project Control Manager Offshore Oil and GasH/F
il y a 4 jours
Île-de-France, France MPH Temps pleinMissions: o all contracts (EPCs, Licensing, long term lease agreements, contracts for Field Operations…). Overall value well above the CAPEX value of the Project.o the overall budget (LOP/Annual and OPEX)o the cost controlo Planning and reportingo Relations with the authorities and our partnerso Risk managemento Doc Controlo IT / offices / logistics and...
-
Project Management Officer
il y a 1 jour
Île-de-France Sqorus Travail à distance Freelance Temps pleinLes attendus de la mission du PMO Learning : Définition et application de la méthodologie projet sur le Learning Suivi projet dans le rétroplanningPlanification de la comitologie Audit de la méthodologie projet Respect de la standardisation de la gestion de projet en lien avec les objectifs projet Coordination des différents stakeholders Le PMO...
-
Project Manager
il y a 3 jours
France Glocomms Temps pleinLocation : Paris, Ile-de-FranceStart Date : 02/09/2024Contract Status : Either CDI or 12-Month Extendable Sub-ContractSalary Expectation : 80-120k€ or 700-900€ per dayOn-site : 2 Days per WeekOur customer is one of the World's Biggest Luxury Retailers who's HQ is in central Paris. They are under-going a large scale digital transformation and...