Clinical Research Manager Job - United States
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Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
The primary responsibility of the Clinical Research Manager (CRM) in Merck Animal Health (MAH) is to design, coordinate, monitor, and report Pre-Clinical and Clinical field and/or laboratory studies that will support the regulatory approval of new Companion Animal and Livestock Pharmaceutical and Biological products. These studies must be conducted in compliance with the requirements of Good Clinical Practice (GCP) or Good Laboratory Practice (GLP) as applicable.
Key responsibilities include and are not limited to the following:
- Designs clinical studies in close collaboration with the project leader, Regulatory Affairs (RA) and other stakeholders as appropriate. This includes the setting of objectives, budgets, resources, timelines and the study protocol.
- Ensures that the study is conducted and reported according to legal requirements, relevant regulatory standard (e.g. GCP, GLP) and the applicable internal policies and procedures.
- Maintains contact with the all stakeholders (project leader, RA, Quality Assurance (QA) etc. and keeps them informed of the study progress.
- Prepared submission dossiers, in collaboration with Regulatory Affairs, and interacts with relevant regulatory agencies (e.g. FDA, EPA, USDA) to support projects, as required.
- Develops and maintains a network of clinical and scientific contacts.
- Required: DVM or PhD in a relevant animal health discipline
- Preferred: Board certification in relevant veterinary discipline
- Minimum of (3) years experience in pharmaceutical or biological research, which may include graduate study in a relevant scientific field.
- Familiarity with MS Office programs
- High level of organizational skills
- Ability to complete tasks independently while working collaboratively as part of a team.
- Ability to communicate internally with colleagues representing different disciplines and with external research partners and regulatory agencies.
- Position may require 50% Travel
- Minimum of (3) years experience in animal health clinical research and accompanying familiarity with principles of Good Clinical Practice.
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at firstname.lastname@example.org.
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Visa sponsorship is not available for this position.
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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Clinical Research (Non-M.D.)
Job Title:Assoc Prin. Scientist, Clinical Research
Primary Location: NA-US-NJ-Madison
Employee Status: Regular
Travel: Yes, 50 % of the Time
Number of Openings: 1
Company Trade Name:Merck
Nearest Major Market: New Jersey
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