Parasitology - Clinical Research

Role Summary

Role: Parasitology - Clinical Research Manager I. This position is within US Clinical Operations, Global Clinical Research and Development, Veterinary Medicine Research & Development (VMRD).

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 for regulatory submission.
• 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 (clinical sampling, test material administration and clinical observations).
• Serve as the principal communication link between the Sponsor and study sites; maintain study files per SOPs and regulatory requirements.
• Implement and execute data management processes including paper and electronic data capture, entry, review, tracking, and verification using electronic tools and centralized data management systems.
• Prepare study files, author study reports and review technical section summaries for regulatory submissions (FDA, EMA, EPA).
• Lead multi-functional teams as a project team member or clinical team lead.
• Contribute to, review and/or author manuscripts for journal publication and present results internally and to external scientific audiences.
• Travel: approximately 10 - 40% annually, variable depending on project status.

Qualifications

• Required: Five years' experience as a clinical study coordinator/monitor or in research/product development in the animal health pharmaceutical industry.
• Required: Experience in the study design and execution of parasitology laboratory clinical studies; familiarity with parasitology study designs and models and regulatory guidance for parasitology studies.
• Required: Previous experience with preparation of regulatory submissions for FDA, EPA and/or EMA; experience working with veterinary clinics and/or research facilities.
• Required: Experience with Good Clinical Practice and/or Good Laboratory Practices.
• Required: Ability to work effectively as part of a team and independently; strong organizational, planning, time management, quality, and attention to detail.
• Required: Excellent interpersonal, written, and oral communication skills; proficiency with Microsoft Office (Outlook, Word, Excel, OneNote, Teams); experience configuring studies in electronic data capture/eClinical software.
• Preferred: Experience and leadership of companion animal clinical field studies.
• Preferred: Education and clinical experience in veterinary technology.
• Preferred: Competence with electronic data capture, eClinical software or remote communication tools.
• Preferred: MS or MPS in Veterinary Parasitology, Veterinary Biomedical Science, or Veterinary Public Health.

Education

• Minimum: Bachelor's degree
• Desirable: Master's degree

Additional Requirements

• Travel: approximately 10 - 40% on an annual basis; variable depending upon project status.