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Job Description
Avec le soutien des chefs de recherche clinique et/ou du directeur du domaine thérapeutique/directeur de recherche clinique, le titulaire de ce poste est responsable de la gestion de bout-en-bout du rendement et des projets pour les protocoles attribués dans un pays conformément à la Conférence internationale d'harmonisation, aux Bonnes pratiques cliniques et aux réglementations du pays, aux politiques et aux procédures de notre entreprise, aux normes de qualité et aux exigences de signalement des événements indésirables tant à l'interne qu'à l'externe.
Le chef associé (e), Recherche clinique pourrait avoir la responsabilité d'une étude particulière pour un pays ou un groupement donné.
Les responsabilités comprennent, entre autres :
Agir comme point de contact principal pour les protocoles attribués et comme agent de liaison entre les Opérations du pays et l'équipe d'essais cliniques.
Être responsable de la gestion de projet des études assignées :planifier de manière proactive, mener et assurer le suivi de l'exécution et du rendement des livrables/échéanciers/résultats afin de répondre aux engagements du pays, de la faisabilité et de la sélection du site, au recrutement, à l'exécution et à la fermeture;
être responsable de l'exécution et de la conformité pour les protocoles attribués dans un pays conformément à la Conférence internationale d'harmonisation, aux Bonnes pratiques cliniques et aux réglementations du pays, aux politiques et aux procédures de notre entreprise, aux normes de qualité et aux exigences de signalement des événements indésirables tant à l'interne qu'à l'externe;
examiner les rapports sur les visites de surveillance et signaler les problèmes de rendement et les besoins de formation au chef associé, Recherche clinique et/ou au fournisseur fonctionnel et à la direction interne au besoin;
effectuer des visites de contrôle de la qualité, au besoin;
diriger les équipes d'étude locales pour assurer un rendement élevé : former d'autres rôles locaux au sujet des protocoles; collaborer étroitement avec les associés, Recherche clinique et les soutenir en tant qu'expert des protocoles; coordonner les activités entre les différents rôles locaux au sein du pays, en favorisant une solide collaboration (y compris avec les coordonnateurs, Essais cliniques, les associés, Recherche clinique et le chef, Opérations cliniques);
créer et exécuter un plan local de gestion des risques pour les études attribuée;
assurer la conformité au Système de gestion d'essais cliniques, à la fiche électronique maîtresse des essais et à d'autres systèmes clés dans les études attribuées;
acheminer au besoin différents problèmes et différentes questions au chef du champ thérapeutique, au directeur, Recherche clinique, au chef, Qualité clinique du pays et/ou à l'équipe d'essais cliniques (selon le cas).
détecter les meilleures pratiques;
collaborer avec les fournisseurs de services fonctionnels en impartition, les chercheurs et d'autres partenaires externes dans les études attribuées.
en tant que poste en contact avec les clients, bâtir des relations d'affaires et représenter notre entreprise auprès des chercheurs;
appuyer l'élaboration de stratégies locales et régionales conformes aux besoins organisationnels à long terme, en collaboration avec le directeur, Recherche clinique, le chef du champ thérapeutique et les Opérations régionales;
collaborer au sein de l'entreprise avec les fonctions du Siège social, les opérations régionales et locales, le développement clinique de l'Union européenne, la pharmacovigilance, les affaires réglementaires, les affaires médicales et scientifiques dans le monde entier afin de s'aligner pour les questions essentielles/décisions dans toutes les études; consulter la Division mondiale des produits pharmaceutiques, au besoin.
Compétences :
Connaissances de la gestion de projet et/ou de la gestion de site.
Fortes aptitudes en organisation avec une réussite avérée dans un poste ou une discipline connexe.
Nécessite la capacité de prendre des décisions de façon indépendante et de superviser de nombreuses activités se rapportant à la recherche clinique dans le pays, conformément aux politiques et aux engagements prédéterminés à l'échelle mondiale et avec le soutien, la direction et la supervision du directeur, Recherche clinique.
Nécessite la compréhension de l'environnement réglementaire local.
Connaissances en recherche scientifique et clinique requises.
Compréhension de la planification, de la gestion et des outils de mesure des essais cliniques essentielle, ainsi que capacité à se concentrer sur plusieurs produits livrables et protocoles simultanément.
Capacité à agir en tant que lien entre les Opérations du pays et les équipes des essais cliniques.
Capacité à communiquer efficacement et à créer un esprit de collaboration entre les pays, les cultures et les fonctions dans un contexte à distance/virtuel.
Capacité à gérer les processus (et les contrôles), la productivité, la qualité et la livraison de projet.
Maîtrise du français, à l'oral et à l'écrit.
Réflexion stratégique.
Capacité à travailler efficacement à distance et en mode virtuel.
Capacité à développer des aptitudes en leadership qui permettent et encouragent l'alignement avec les buts, objectifs et la mission des laboratoires de recherche de l'entreprise, des divisions Développement clinique mondial et Opérations mondiales liées aux essais cliniques.
La capacité d'identifier rapidement les problèmes, les conflits et les occasions et de diriger, d'analyser et de préparer des plans d'atténuation et de favoriser la résolution des conflits est essentielle.
Capacité de négocier habilement lors de situations difficiles avec des groupes internes et externes et de régler les différends avec une perturbation minimale.
Voici des exemples de problèmes courants : 1) faible recrutement des patients, 2) personnel inadéquat pour répondre aux besoins de l'entreprise, 3) problèmes de rendement ou de conformité, et 4) la résolution de situations conflictuelles à l'échelle du pays.
Compréhension de la diversité culturelle.
Solides compétences en diplomatie et en empathie pour établir et maintenir efficacement des relations professionnelles avec les chercheurs et d'autres intervenants.
Qualifications et expérience :
Minimum 4 ans en recherche clinique
Baccalauréat en sciences (ou l'équivalent)
Expérience en tant qu'associé de recherche clinique est préférée
Déplacements à prévoir : Jusqu'à 30 % du temps de travail
Conformément à la Stratégie de milieu de travail hybride de notre entreprise, ce poste sera exécuté au moyen d'une combinaison de travail à distance et de travail en personne (siège social de Kirkland) en fonction de la nature du travail à effectuer.
Nous sommes fiers d'être une entreprise qui embrasse la valeur de rassembler des personnes diversifiées, talentueuses et engagées. La façon la plus rapide d'innover est de rassembler des gens de diverses opinions dans un environnement inclusif. Nous encourageons nos collègues à remettre en question avec respect les problèmes de réflexion et d'approche de l'un et de l'autre. Nous sommes un employeur souscrivant au principe de l'égalité d'accès à l'emploi et nous sommes déterminés à favoriser un milieu de travail inclusif et diversifié.
Current Employees apply HERE
Current Contingent Workers apply HERE
Secondary Language(s) Job Description:
With support of other Clinical Research Managers and/or Therapeutic Area Head/Clinical Research Director, this role is accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with International Conference on Harmonization/Good Clinical Practice and country regulations, our Company's policies and procedures, quality standards and adverse event reporting requirements internally and externally.
The Associate Clinical Research Manager could be accountable for a particular study for a country or a cluster.
Responsibilities include, but are not limited to:
Main Point of Contact for assigned protocols and link between Country Operations and clinical trial team.
Accountable for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.
Accountable for performance for assigned protocols in a country in compliance with International Conference on Harmonization/Good Clinical Practice and country regulations, our Company's policies and procedures, quality standards and adverse event reporting requirements internally and externally.
Reviews Monitoring Visits Reports and escalates performance issues and training needs to Clinical Research Associate-Manager and/or functional vendor and internal management as needed.Performs Quality control visits.
Directs local study teams to high performance: trains in the protocol other local roles, closely works with and supports Clinical Research Associates as protocol expert and coordinates activities across the different local country roles ensuring a strong partnership (including the Clinical Trial Coordinators, Clinical Research Associates and Clinical Operation Managers).
Accountable for creating and executing a local risk management plan for assigned studies.
Ensures compliance with Clinical Trial Management System, electronic Trial Master File and other key systems in assigned studies.
Escalates as needed different challenges and issues to Therapeutic Area-Head/Clinical Research Director/ Country Clinical Quality Manager and or Clinical Trial Team (as appropriate).
Identifies and informs on best practices.
Accountable for partnership with functional outsourcing vendors, investigators, other external partners in assigned studies.
As a customer-facing role, this position will build business relationships and represent our Company with investigators.
Supports local and regional strategy development consistent with long‐term corporate needs in conjunction with Clinical Research Director, Therapeutic Area-Head and Regional Operations.
Partners internally with Headquarter functions, regional and local operations, European Union Clinical Development, Pharmacovigilance, Regulatory Affairs, Global Medical and Scientific Affairs to align on key issues/decisions across the trials. Consult with Human Health as needed.
Skills:
Knowledge in Project Management and/or site management.
Strong organizational skills with demonstrated success in related role or discipline.
Ability to make decisions freely and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments with the support, oversight and supervision of the Therapeutic Area-Head or Clinical Research Director
Strong comprehension of local regulatory environment.
Scientific and clinical research knowledge.
Comprehension of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
Ability to function as a key link between Country Operations and Clinical Trial Teams
Speaks effectively and builds a partnership spirit in a remote/virtual environment and across countries, cultures and functions.
Ability to manage processes (and controls), productivity, quality and project delivery.
Required language: French (written and spoken).
Strategic thinking.
Ability to work efficiently in a remote and virtual environment.
Aptitude for building influencing skills that enable and drive alignment with the goals, purpose and mission of Company's Research Labs, Global Clinical Development and Global Clinical Trial Operations divisions.
Ability to identify problems, conflicts and opportunities early, analyses and prepare mitigation plans and drive conflict resolution is critical.
Ability to negotiate skillfully in tough situations with both internal and external groups; settle differences with minimum disruption.
Examples of common problems include: 1) low patient recruitment, 2) inadequate staff to meet business needs, 3) performance or compliance issues, and 5) resolution of conflictive situations.
Appreciate cultural diversity.
Strong diplomatic and empathic skills to effectively build and maintain professional relationships with investigators and other stakeholders.
Qualification & Experience:
4+ years in clinical research
Bachelor's degree in Science
Clinical Research Associate experience is preferred
Extent of Travel: Up to 30% of working time
In line with our Company's Hybrid Workplace Strategy, this position will be performed through a combination of remote work and in-person (Kirkland Head Office) based on the nature of work to be done.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
25%Flexible Work Arrangements:
HybridShift:
1st - DayValid Driving License:
YesHazardous Material(s):
NAJob Posting End Date:
08/19/2024*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date:08/19/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R307972