Job Description:
• Participate on project teams to develop and license veterinary parasiticides
• Coordinate or lead the coordination of all study activities, including study 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 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
Requirements:
• Bachelor'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
• Ability to work both as a member of a team and independently in a self-directed and self-motivated manner
• Excellent skills in 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.
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