Key skills
Communication
About this role
Role Overview
- 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 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
- Prepare study files, author study reports and review technical section summaries for submission to regulatory agencies
- Lead multi-functional team(s)
- 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
Requirements
- Minimum: Bachelor's degree
- Desirable: Master’s degree
- Minimum: 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
- Competence with Microsoft Office Products (Outlook, Word, Excel, OneNote, Teams)
Benefits
- healthcare and insurance benefits beginning on day one
- 401K plan with a match and profit-sharing contribution from Zoetis
- 4 weeks of vacation
- short-term incentive compensation
- long-term incentives