Job Description

Position Description:Global Clinical Trial Operations (GCTO) is a global organization operating in over 50 countries and is responsible in the delivery of our company\'s diverse development portfolio comprising over 200 clinical trials in compliance with global and local regulations. The Regional Operations organization is comprised of 4 distinct regions (North America, Latin America, Asia Pacific, and Europe) and is responsible for a significant proportion of the GCTO budget, staff and deliverables.Global Site Agreements (GSA) is an organization within GCTO that drafts, negotiates, and executes agreements on a global basis in support of our company\xe2\x80\x99s research development and clinical trial portfolio. We are responsible for negotiating clinical trial agreements, confidentiality agreements, and other type of agreements related to clinical research.As a GSA Specialist you will work closely with experienced GSA team to:Review, escalate and stamp site CTRA and other type of the site agreements (e.g. MCTRA, FUA, CSA for both in- and outsourced trials.); and/or draft, negotiate, and execute scientific input Consulting Agreements and our company\'s Investigator Studies Program (MISP) agreements; and/or negotiate and execute licensing and translation vendor agreements in support of our company\xe2\x80\x99s use of clinical outcome assessments (COA)Act as liaison to our company\'s Office of General Counsel, Privacy, Compliance and Clinical Teams, as appropriate, to resolve contractual/legal issues with sites, investigators, consultants and vendors.Maintain high level of collaboration and interaction with the GCTO Country Operations/Research Division Functional area and act as a liaison with Global Operations.Participate in regional and global improvement projects, identify and propose improvements to the internal systems or processes to ensure high compliance and efficiency standards.Support appropriate GCTO region/Research Division functional area meetings and trainings to ensure understanding of contracting process.Support departmental initiatives including filing, metric reporting and quality control.Position Qualifications:Education Minimum Requirement:A minimum of an Associate\xe2\x80\x99s Degree with 10 years of relevant experience in the pharmaceutical industry required OR a Bachelor\xe2\x80\x99s Degree with a minimum of 3 years of relevant experience in the pharmaceutical industryRequired Experience and Skills:Demonstrated strong ability in communication, presentation and writing skillsExcellent analytical abilityGood team player and ability to work independently in a global setting Microsoft Office and data analytics proficiencyPrior work experience in clinical outcome assessment licensing and translations agreement negotiation (preferred)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\xe2\x80\x99s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.Current Employees applyCurrent Contingent Workers applySecondary Language(s) :Description de poste:L\xe2\x80\x99organisation mondiale des essais cliniques est une organisation mondiale pr\xc3\xa9sente dans plus de 50 pays et est charg\xc3\xa9e de la r\xc3\xa9alisation du portefeuille diversifi\xc3\xa9 de d\xc3\xa9veloppements de notre entreprise, comprenant plus de 200 essais cliniques, conform\xc3\xa9ment aux r\xc3\xa9glementations mondiales et locales.L\'organisation des op\xc3\xa9rations r\xc3\xa9gionales est compos\xc3\xa9e de 4 r\xc3\xa9gions distinctes (Am\xc3\xa9rique du Nord, Am\xc3\xa9rique latine, Asie-Pacifique et Europe) et est responsable d\'une part importante du budget, du personnel et des livrables de l\xe2\x80\x99organisation mondiale des essais cliniques. Global Site Agreements (GSA) est une organisation au sein de l\xe2\x80\x99organisation mondiale des essais cliniques qui r\xc3\xa9dige, n\xc3\xa9gocie et ex\xc3\xa9cute des accords \xc3\xa0 l\'\xc3\xa9chelle mondiale pour soutenir le d\xc3\xa9veloppement de la recherche et le portefeuille d\'essais cliniques de notre entreprise. Nous sommes responsables de la n\xc3\xa9gociation des accords d\'essais cliniques, des accords de confidentialit\xc3\xa9 et d\'autres types d\'accords li\xc3\xa9s \xc3\xa0 la recherche clinique.En tant que Sp\xc3\xa9cialiste, accords mondiaux avec les sites, vous travaillerez en \xc3\xa9troite collaboration avec une \xc3\xa9quipe GSA exp\xc3\xa9riment\xc3\xa9e pour :Examiner, escalader et apposer un cachet sur les protocoles d\'accord avec les sites (CTRA) et d\'autres types d\'accords avec les sites (par exemple, CTRA - Accord de recherche sur les essais cliniques MCTRA - Accord-cadre de recherche sur les essais cliniques, FUA - Accord d\'utilisation des installations CSA - Accord de services cliniques) pour les essais externalis\xc3\xa9s et internes; et/ou r\xc3\xa9diger, n\xc3\xa9gocier et ex\xc3\xa9cuter des accords de consultation scientifique et des accords de notre programme d\'\xc3\xa9tudes des investigateurs ; et/ou n\xc3\xa9gocier et ex\xc3\xa9cuter des accords de licence et de traduction avec des fournisseurs pour soutenir l\'utilisation des \xc3\xa9valuations cliniques de r\xc3\xa9sultats (COA) par notre entreprise.Agir en tant que liaison avec le bureau du conseiller juridique g\xc3\xa9n\xc3\xa9ral, la confidentialit\xc3\xa9, la conformit\xc3\xa9 et les \xc3\xa9quipes cliniques de notre entreprise, si cela est n\xc3\xa9cessaire, pour r\xc3\xa9soudre les probl\xc3\xa8mes contractuels/juridiques avec les sites, les investigateurs, les consultants et les fournisseurs.Maintenir un niveau \xc3\xa9lev\xc3\xa9 de collaboration et d\'interaction avec les op\xc3\xa9rations pays/recherche de l\xe2\x80\x99organisation mondiale des essais cliniques et agir en tant que lien avec les op\xc3\xa9rations mondiales.Participer \xc3\xa0 des projets d\'am\xc3\xa9lioration r\xc3\xa9gionaux et mondiaux, identifier et proposer des am\xc3\xa9liorations aux syst\xc3\xa8mes internes ou aux processus pour garantir des normes de conformit\xc3\xa9 et d\'efficacit\xc3\xa9 \xc3\xa9lev\xc3\xa9es. \xe2\x80\xa2 Apporter un soutien aux r\xc3\xa9unions et formations appropri\xc3\xa9es du domaine fonctionnel des op\xc3\xa9rations pays/recherche de l\xe2\x80\x99organisation mondiale des essais cliniques pour assurer une compr\xc3\xa9hension du processus de contractualisation.Soutenir les initiatives du service, notamment le classement, le rapport de statistiques et le contr\xc3\xb4le de la qualit\xc3\xa9.Qualifications requises pour le poste :Formation :Un dipl\xc3\xb4me coll\xc3\xa9gial au minimum avec 10 ans d\'exp\xc3\xa9rience pertinente dans l\'industrie pharmaceutique est requis, OU un dipl\xc3\xb4me de baccalaur\xc3\xa9at avec un minimum de 3 ans d\'exp\xc3\xa9rience pertinente dans l\'industrie pharmaceutique.Exp\xc3\xa9rience et comp\xc3\xa9tences requises :Comp\xc3\xa9tences d\xc3\xa9montr\xc3\xa9es en communication, pr\xc3\xa9sentation et r\xc3\xa9dactionExcellente capacit\xc3\xa9 d\'analyse\xc2\xb7Bon esprit d\'\xc3\xa9quipe et capacit\xc3\xa9 \xc3\xa0 travailler de mani\xc3\xa8re autonome dans un contexte mondialMa\xc3\xaetrise de Microsoft Office et des outils d\'analyse de donn\xc3\xa9es.Exp\xc3\xa9rience ant\xc3\xa9rieure dans l\'\xc3\xa9valuation clinique des r\xc3\xa9sultats et dans la n\xc3\xa9gociation des accords de traduction et de licence (un atout).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 d\xe2\x80\x99innover 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 d\xe2\x80\x99approche de l\xe2\x80\x99un et de l\xe2\x80\x99autre. Nous sommes un employeur souscrivant au principe de l\xe2\x80\x99\xc3\xa9galit\xc3\xa9 d\xe2\x80\x99acc\xc3\xa8s \xc3\xa0 l\xe2\x80\x99emploi et nous sommes d\xc3\xa9termin\xc3\xa9s \xc3\xa0 favoriser un milieu de travail inclusif et diversifi\xc3\xa9.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: 10%Flexible Work Arrangements: HybridShift: Not IndicatedValid Driving License: NoHazardous Material(s): NAJob Posting End Date: 08/23/2024*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.

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