M

Merck

Makes medicines, vaccines and animal treatments

Associate Principal Scientist - Clinical Research

Clinical Research OperationsPosted on Nov 9
Full-timeRahway, NJ, USA

About the Job

Requirements

  • A Doctor of Veterinary Medicine or equivalent veterinary degree is required.
  • At least four years of experience in clinical research or a similar research role is required.
  • Experience in a clinical study-related role is required.
  • Strong scientific writing ability is required.
  • Proficient verbal and written communication is required.
  • Proficiency in Microsoft Office applications is required.
  • Understanding of Good Clinical Practice guidelines is required.
  • Knowledge or experience in biomarker assay development, clinical site management, clinical study design, clinical trials operations, ethical compliance and standards, multiple therapeutic areas, patient recruitment, medical writing, and veterinary research is required.

Responsibilities

  • Design and conduct clinical studies that adhere to scientific, regulatory, and ethical requirements and support registration of animal health products.
  • Design and organize paper and Electronic Data Capture clinical studies by setting objectives, budgets, resources, timelines, study protocols, and related documentation.
  • Provide overall leadership and support to the clinical study team.
  • Identify and select investigators, laboratories, and contract research organizations.
  • Apply for necessary study permits and licenses with support from local regulatory staff within the specified study timeline.
  • Train the study team on the study protocol.
  • Ensure timely selection and ordering of study materials.
  • Ensure that study administrative matters, including budgets and agreements, comply with applicable laws and company policies and procedures.
  • Plan and coordinate monitoring and data management activities for each study.
  • Ensure studies are conducted in accordance with legal requirements, Good Clinical Practice, and applicable internal policies and procedures.
  • Prepare the final study report.
  • Maintain contact with stakeholders, including the project leader, regulatory affairs, and quality assurance, and keep them informed of study progress.
  • Serve as the Global Clinical Research representative on the project team when assigned.
  • Perform monitoring and data management tasks, such as user acceptance testing of electronic case report forms.
  • Develop and maintain a network of internal and external clinical and scientific contacts and key opinion leaders in relevant fields.
  • Serve as a contact and liaison with internal departments on specific projects and with external partners, including universities and regulatory authorities.
  • Prepare critical summaries and expert reports for management or submission to regulatory agencies.
  • Supervise trainees and provide mentorship and support to other Global Clinical Research staff.
  • Provide scientific and technical support to marketing groups for key molecules or products and provide clinical research expertise upon request.
  • Conduct post-marketing studies.
  • Prepare scientific publications as needed by the company.

About the Company

Merck

Makes medicines, vaccines and animal treatments

Merck develops prescription medicines, vaccines and veterinary treatments for patients, health systems and animal owners worldwide. Its vaccine portfolio includes Gardasil 9, which helps prevent cancers and other diseases caused by several types of human papillomavirus. The company takes potential treatments through laboratory research and clinical trials, then manufactures and sells approved products to drug distributors, hospitals, physicians and governments. Its animal health division sells medicines and vaccines to veterinarians, farmers and pet owners, while selected drug partnerships also earn shared profits or royalties. Founded in 1891, Merck is headquartered in Rahway, New Jersey.

Company size
10,001+
Company stage
IPO
Headquarters
Rahway, NJ
Founded
1891

Recently Posted Jobs

Explore more opportunities at Merck

See more jobs