Clinical Research Manager (Animal Health)

Job Description

Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, in accordance with applicable law.

Our Animal Health Research Laboratories team work tirelessly to invent solutions to improve the health and wellbeing of animals. Our state-of-the-art research facilities create an environment of innovation that enable us to create breakthrough science changing the way we approach animal health challenges.

The primary function of the Clinical Research Manager (CRM) position is to design, coordinate, monitor, and report clinical laboratory and field studies that will support the regulatory approval of new companion animal and livestock products. The position requires the candidate to be responsible for the conduct of Good Clinical Practice (GCP) studies, and occasionally Good Laboratory Practice (GLP) studies.

The CRM acts primarily as clinical study team leader and has overall responsibility for a study. Specifically, the CRM has the following tasks and responsibilities:
  • Design and organization of paper and Electronic Data Capture (EDC) clinical studies that meet scientific and regulatory requirements. This includes the setting of objectives, budget, resources, timelines and the study protocol/related documentation
  • Provide overall leadership and support to the study team
  • Identify and select Investigators, laboratories and/or CROs.
  • Apply for the necessary study permits and licenses "" with support of local regulatory staff "" within the specified study timeline
  • Train the study team on the Study Protocol, as appropriate.
  • Ensure the timely selection and ordering of study materials.
  • Ensure compliance of the administrative aspects of the study (budgets and agreements) with the applicable laws and our Company's policies and procedures. Plan and coordinate the monitoring and data management activities of each study.
  • Ensure that the study is conducted according to legal requirements, GCP, and the applicable internal policies and procedures.
  • Prepare the Final Study Report.
  • Maintain contact with the all stakeholders (project leader, regulatory affairs, quality assurance etc.) and keeps them informed of the study progress.
  • May be the GCR representative in the project team.


In addition the CRM:
  • Can assume responsibility for certain monitoring and data management tasks (e.g. User Acceptance Test of electronic CRFs).
  • Can monitor clinical studies under the leadership of other CSTLs.
  • Develops and maintains a network of internal and external clinical and scientific contacts and key opinion leaders in relevant fields.
  • Perform quality control inspections of study protocol, study documentation files and reports as appropriate.
  • When required, serves as a contact and liaison with other internal departments on specific projects, and with external partners, such as universities or regulatory authorities.
  • Prepares critical summaries and expert reports to management and/or for submission to regulatory agencies.
  • Supervise trainees and provide mentorship and support to other GCR staff as appropriate.
  • Provides scientific and technical support to the marketing groups for key molecules/products and clinical research expertise upon request.
  • Conducts post-marketing studies.
  • Prepares scientific publications (articles, oral communications, posters) according to the need of the company.


Requirements:
  • A Doctor of Veterinary Medicine, OR equivalent veterinary degree.
  • A minimum of four (4) years of experience in clinical research or similar research role.
  • Experience in a clinical study related role.
  • Strong scientific writing ability.
  • Good written and oral command of English language.
  • Good communication skills.
  • Proficient in MS Office applications.


Preferred Experience and Skills:
  • An advanced degree (e.g. PhD) and/or board certification by an AVMA-accredited organization.
  • A minimum of five (5) years of experience in clinical research or equivalent role.


Our Animal Health Division is a trusted global leader in veterinary medicine, dedicated to preserving and improving health, well-being, and performance of animals and the people who care for them. We are a global team of professionals working together to make a positive difference in animal care and the world's food supply and have a deep sense of responsibility towards our customers, consumers, animals, society, and our planet.

Through our commitment to The Science of Healthier Animals®, we offer veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of digitally connected identification, traceability and monitoring products. We invest in dynamic and comprehensive R&D resources and a modern, global supply chain. We are present in more than 50 countries, while our products are available in some 150 markets.

Who we are ...

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for ...

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

NOTICE FOR INTERNAL APPLICANTS

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.

Residents of Colorado

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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., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:
Domestic

VISA Sponsorship:
No

Travel Requirements:
25%

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:
1

Requisition ID:R140011