Parasitology – Clinical Research

Zoetis

9d • $93,000 - $150,000

About The Position

The successful applicant embodies Zoetis’ Core Beliefs: Our Colleagues Make The Difference, Always Do The Right Thing, Customer Obsessed, Run It Like You Own It, and We Are One Zoetis. Within US Clinical Operations, the candidate will be assigned to one or more Project Teams and will have the following duties and responsibilities: Participate on project teams to develop and license veterinary parasiticides. As a member of the clinical team, coordinate or lead the coordination of all study activities, including start up, Investigator training, conduct, site monitoring and close out. These may include, but are not limited to: Prepare study protocols, amendments, deviations, data capture forms, electronic data capture systems, test article documentation and study reports in preparation for submission to regulatory agencies. Collaborate with multiple internal partner groups to plan, coordinate, conduct, analyze, and report studies. Develop training materials and conduct training of Investigators and other study site personnel. Coordinate animal related study activities (i.e. clinical sampling, test material administration and clinical observations). Serve as the principal communication link between the Sponsor and study sites. Maintain study files in accordance with SOPs and regulatory requirements. Implement and execute data management processes including paper and electronic data capture, entry, review, tracking, and verification utilizing electronic tools and centralized data management systems. Prepare study files, author study reports and review technical section summaries for submission to regulatory agencies (FDA, EMA, EPA). Lead multi-functional team(s) serving as a project team member or clinical team lead. Contribute to, review and/or author manuscripts for journal publication. Present results, as needed, both internally and to external scientific audiences. Travel: approximately 10 – 40% on an annual basis. Variable, depending upon project status.

Requirements

• Minimum: Bachelor's degree
• Five years’ experience as a clinical study coordinator/monitor or in research/product development in the animal health pharmaceutical industry
• Experience in the study design and execution of parasitology laboratory clinical studies.
• Familiarity with parasitology study designs and models as well as regulatory guidance/expectations for the conduct and execution of parasitology studies.
• Previous experience with preparation of regulatory submissions for FDA, EPA and/or EMA for product registration
• Previous experience working with veterinary clinics and/or research facilities.
• Experience with Good Clinical Practice and/or Good Laboratory Practices.
• Ability to work both as a member of a team and independently in a self-directed and self-motivated manner.
• Excellent skills in the following competencies: organizing, planning, time management, quality, attention to detail.
• Well-developed critical thinking skills with the ability to learn on the fly and problem solve.
• Excellent interpersonal skills with very good written and oral communication skills.
• Competence with Microsoft Office Products (Outlook, Word, Excel, OneNote, Teams).
• Experience in configuring studies in an electronic data capture platform/ eClinical software.

Nice To Haves

• Master’s degree
• Experience and interest in the conduct and leadership of companion animal clinical field studies.
• Education and clinical experience in the field of veterinary technology.
• Competence with electronic data capture, eClinical software or remote communication tools.
• MS or MPS in Veterinary Parasitology, Veterinary Biomedical Science or Veterinary Public Health.

Responsibilities

• Participate on project teams to develop and license veterinary parasiticides.
• Coordinate or lead the coordination of all study activities, including start up, Investigator training, conduct, site monitoring and close out.
• Prepare study protocols, amendments, deviations, data capture forms, electronic data capture systems, test article documentation and study reports in preparation for submission to regulatory agencies.
• Collaborate with multiple internal partner groups to plan, coordinate, conduct, analyze, and report studies.
• Develop training materials and conduct training of Investigators and other study site personnel.
• Coordinate animal related study activities (i.e. clinical sampling, test material administration and clinical observations).
• Serve as the principal communication link between the Sponsor and study sites.
• Maintain study files in accordance with SOPs and regulatory requirements.
• Implement and execute data management processes including paper and electronic data capture, entry, review, tracking, and verification utilizing electronic tools and centralized data management systems.
• Prepare study files, author study reports and review technical section summaries for submission to regulatory agencies (FDA, EMA, EPA).
• Lead multi-functional team(s) serving as a project team member or clinical team lead.
• Contribute to, review and/or author manuscripts for journal publication.
• Present results, as needed, both internally and to external scientific audiences.

Benefits

• This position is also eligible for short-term incentive compensation
• This position is also eligible for long-term incentives
• Zoetis offers a comprehensive benefits package that supports the physical, emotional and financial wellbeing of our colleagues and their families including healthcare and insurance benefits beginning on day one, a 401K plan with a match and profit-sharing contribution from Zoetis, and 4 weeks of vacation.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees