Parasitology - Clinical Research

Role Summary

Parasitology - Clinical Research

Manager I (Parasitology) 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 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.

Qualifications

• Educational Background: Minimum: Bachelor's degree; Desirable: Master's degree
• Work Experience/Skills: 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.
• Desirable: 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.

Skills

• Project coordination and leadership
• Clinical study design and execution
• Regulatory submission preparation
• Data management and electronic data capture
• Scientific writing and presentation
• Communication and collaboration across cross-functional teams
• Proficiency with Microsoft Office and eClinical software

Education

• Bachelor's degree required; Master's degree preferred