Specialist, Clinical Operations

Job Description

Position Description:

Specialist, Clinical Operations

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's 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's 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's Degree with 10 years of relevant experience in the pharmaceutical industry required OR a Bachelor's Degree with a minimum of 3 years of relevant experience in the pharmaceutical industry

Required Experience and Skills:

• Demonstrated strong ability in communication, presentation and writing skills
• Excellent analytical ability
• Good team player and ability to work independently in a global setting Microsoft Office and data analytics proficiency

Preferred Experience and Skills:

• Prior work experience in clinical outcome assessment licensing and translations agreement negotiation

MRLGCTO

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MSJR

NOTICEFORINTERNALAPPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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Secondary Language(s) Job Description

Spécialiste, Accords mondiaux avec les sites - P2

L'organisation mondiale des essais cliniques est une organisation mondiale présente dans plus de 50 pays et est chargée de la réalisation du portefeuille diversifié de développements de notre entreprise, comprenant plus de 200 essais cliniques, conformément aux réglementations mondiales et locales.

L'organisation des opérations régionales est composée de 4 régions distinctes (Amérique du Nord, Amérique latine, Asie-Pacifique et Europe) et est responsable d'une part importante du budget, du personnel et des livrables de l'organisation mondiale des essais cliniques. Global Site Agreements (GSA) est une organisation au sein de l'organisation mondiale des essais cliniques qui rédige, négocie et exécute des accords à l'échelle mondiale pour soutenir le développement de la recherche et le portefeuille d'essais cliniques de notre entreprise. Nous sommes responsables de la négociation des accords d'essais cliniques, des accords de confidentialité et d'autres types d'accords liés à la recherche clinique.

En tant que Spécialiste, accords mondiaux avec les sites, vous travaillerez en étroite collaboration avec une équipe GSA expérimentée 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 externalisés et internes; et/ou rédiger, négocier et exécuter des accords de consultation scientifique et des accords de notre programme d'études des investigateurs ; et/ou négocier et exécuter des accords de licence et de traduction avec des fournisseurs pour soutenir l'utilisation des évaluations cliniques de résultats (COA) par notre entreprise.

• Agir en tant que liaison avec le bureau du conseiller juridique général, la confidentialité, la conformité et les équipes cliniques de notre entreprise, si cela est nécessaire, pour résoudre les problèmes contractuels/juridiques avec les sites, les investigateurs, les consultants et les fournisseurs.

• Maintenir un niveau élevé de collaboration et d'interaction avec les opérations pays/recherche de l'organisation mondiale des essais cliniques et agir en tant que lien avec les opérations mondiales.

• Participer à des projets d'amélioration régionaux et mondiaux, identifier et proposer des améliorations aux systèmes internes ou aux processus pour garantir des normes de conformité et d'efficacité élevées.
• Apporter un soutien aux réunions et formations appropriées du domaine fonctionnel des opérations pays/recherche de l'organisation mondiale des essais cliniques pour assurer une compréhension du processus de contractualisation.

• Soutenir les initiatives du service, notamment le classement, le rapport de statistiques et le contrôle de la qualité.

Qualifications requises pour le poste :

Expérience et compétences requises :

Formation : Un diplôme collégial au minimum avec 10 ans d'expérience pertinente dans l'industrie pharmaceutique est requis, OU un diplôme de baccalauréat avec un minimum de 3 ans d'expérience pertinente dans l'industrie pharmaceutique.

Expérience et compétences requises :

· Compétences démontrées en communication, présentation et rédaction

· Excellente capacité d'analyse

· Bon esprit d'équipe et capacité à travailler de manière autonome dans un contexte mondial

· Maîtrise de Microsoft Office et des outils d'analyse de données.

· Expérience antérieure dans l'évaluation clinique des résultats et dans la négociation des accords de traduction et de licence (un atout).

US and Puerto Rico Residents Only:

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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

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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.

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Job Posting End Date:

*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:05/22/2024

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:R292117