Job Description

Chef, Recherche clinique Ce r\xc3\xb4le est principalement responsable de la gestion de bout en bout du rendement et des projets pour les protocoles attribu\xc3\xa9s dans un pays, conform\xc3\xa9ment aux Bonnes pratiques cliniques de la Conf\xc3\xa9rence internationale sur lharmonisation, aux r\xc3\xa8glements du pays, aux politiques et proc\xc3\xa9dures de notre entreprise, aux normes de qualit\xc3\xa9 et aux exigences de d\xc3\xa9claration des \xc3\xa9v\xc3\xa9nements ind\xc3\xa9sirables, tant \xc3\xa0 linterne qu\xc3\xa0 lexterne. Vos responsabilit\xc3\xa9s principales en tant que Chef, Recherche clinique:

• Agir comme point de contact principal pour les protocoles attribu\xc3\xa9s et comme agent de liaison entre les Op\xc3\xa9rations du pays et l\xc3\xa9quipe dessais cliniques.
• Assurer la gestion de projets pour les \xc3\xa9tudes attribu\xc3\xa9es : planifier, diriger et suivre de fa\xc3\xa7on proactive lex\xc3\xa9cution et le rendement pour les produits livrables/\xc3\xa9ch\xc3\xa9anciers/r\xc3\xa9sultats afin r\xc3\xa9pondre aux engagements du pays, de lanalyse de la faisabilit\xc3\xa9 et de la s\xc3\xa9lection des centres au recrutement, \xc3\xa0 lex\xc3\xa9cution et \xc3\xa0 la cl\xc3\xb4ture des \xc3\xa9tudes.
• G\xc3\xa9rer le rendement pour les protocoles attribu\xc3\xa9s dans un pays, conform\xc3\xa9ment aux Bonnes pratiques cliniques et Conf\xc3\xa9rence internationale sur lharmonisation et aux r\xc3\xa8glements du pays, aux politiques et aux proc\xc3\xa9dures de notre entreprise de m\xc3\xaame quaux normes de qualit\xc3\xa9 et aux exigences de d\xc3\xa9claration des \xc3\xa9v\xc3\xa9nements ind\xc3\xa9sirables, tant \xc3\xa0 linterne qu\xc3\xa0 lexterne.

Vous \xc3\xaates le/la candidat(e) id\xc3\xa9al(e) si vous avez :

• Baccalaur\xc3\xa9at en sciences.
• De cinq \xc3\xa0 six ans dexp\xc3\xa9rience en recherche clinique.
• Minimum d\'un an d\'exp\xc3\xa9rience en gestion de projets des \xc3\xa9tudes cliniques et de la gestion de centre.
• Exp\xc3\xa9rience en tant quassoci\xc3\xa9(e), Recherche clinique, un atout.
• Solide sens de lorganisation avec succ\xc3\xa8s d\xc3\xa9montr\xc3\xa9s.
• Capacit\xc3\xa9 de prendre des d\xc3\xa9cisions de fa\xc3\xa7on autonome et de superviser dimportantes activit\xc3\xa9s se rapportant \xc3\xa0 la recherche clinique, conform\xc3\xa9ment aux politiques et aux engagements pr\xc3\xa9d\xc3\xa9termin\xc3\xa9s \xc3\xa0 l\xc3\xa9chelle mondiale et avec le soutien, la direction et la supervision du chef du champ th\xc3\xa9rapeutique ou du directeur, Recherche clinique.
• Solide compr\xc3\xa9hension de lenvironnement r\xc3\xa9glementaire local.
• Solides connaissances dans le domaine scientifique et la recherche clinique (requises).
• Solide compr\xc3\xa9hension de la planification, de la gestion et des outils de mesure des essais cliniques (essentielle); capacit\xc3\xa9 \xc3\xa0 se concentrer sur plusieurs produits livrables et protocoles simultan\xc3\xa9ment.
• Ma\xc3\xaetrise du fran\xc3\xa7ais, \xc3\xa0 loral et \xc3\xa0 l\xc3\xa9crit.

Conform\xc3\xa9ment \xc3\xa0 la Strat\xc3\xa9gie de milieu de travail hybride de notre entreprise, ce poste sera ex\xc3\xa9cut\xc3\xa9 au moyen dune combinaison de travail \xc3\xa0 distance et de travail en personne (si\xc3\xa8ge social de Kirkland) en fonction de la nature du travail \xc3\xa0 effectuer. Nous sommes fiers d\'\xc3\xaatre une entreprise qui embrasse la valeur de rassembler des personnes diversifi\xc3\xa9es, talentueuses et engag\xc3\xa9es. La fa\xc3\xa7on la plus rapide dinnover est de rassembler des gens de diverses opinions dans un environnement inclusif. Nous encourageons nos coll\xc3\xa8gues \xc3\xa0 remettre en question avec respect les probl\xc3\xa8mes de r\xc3\xa9flexion et dapproche de lun et de lautre. Nous sommes un employeur souscrivant au principe de l\xc3\xa9galit\xc3\xa9 dacc\xc3\xa8s \xc3\xa0 lemploi et nous sommes d\xc3\xa9termin\xc3\xa9s \xc3\xa0 favoriser un milieu de travail inclusif et diversifi\xc3\xa9. Current Employees apply HERE Current Contingent Workers apply HERE Secondary Language(s) : Clinical Research Manager This role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with the International Conference on Harmonisation Good Clinical Practices and country regulations, our Company's policies and procedures, quality standards and adverse event reporting requirements internally and externally. Your key assignments as Clinical Research Manager:

• 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 Harmonisation Good Clinical Practices and country regulations, our Company's policies and procedures, quality standards and adverse event reporting internally and externally.

You are the ideal candidate if you have:

• Bachelor degree in Science.
• 5-6 years of experience in clinical research.
• Minimum 1 year of experience in Project Management of clinical studies and site management.
• Clinical Research Associate Experience preferred.
• Strong organizational skills with demonstrated success.
• Ability to make decisions independently 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.
• Requires strong comprehension of local regulatory environment.
• Strong scientific and clinical research knowledge is required.
• Strong comprehension of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.
• Proficiency in written and spoken in French (written and verbal communication)
  

In line with our Companys 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 anothers 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: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 25% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): No Job Posting End Date: 06/14/2024

• 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:06/14/2024
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:R297241