Clinical Research Manager (Animal Health)
- Florham Park, NJ
Our Animal Health Research & Development team works tirelessly to invent solutions to improve the health and well-being of animals. Our state-of-the-art research facilities provide 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 mentor-ship 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.
- 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 the health and well-being of animals. 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. We offer one of our industry's most innovative portfolio of products, services and technologies that serve to prevent, treat, and control diseases across all major farm and companion animal species.
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.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world's biggest investors in Research & Development.
What we look for ...
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
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.
US and Puerto Rico Residents Only:
If you need an accommodation for the application process please email us at firstname.lastname@example.org
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We are an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.
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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.
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