Specialist, Clinical Operations

2 weeks ago

North Wales, United States Merck Sharp & Dohme Full time

**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

EligibleforERP

ETJOBS

MSJR

**NOTICE** **FOR** **INTERNAL** **APPLICANTS**

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.**

**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

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