Position Summary
The position will support and/or manage clinical research studies in compliance with appropriate regulatory requirements to support the qualification/requalification of biological references. Depending on experience the the candidate will be part of the clinical team that ensures quality data and timely completion of studies to meet project timelines or provides extensive knowledge and expertise in the areas of study conduct, species/therapeutic area or clinical program.
Position Responsibilities
Associate / Sr Associate
Assist/Co-ordinate all study activities, including start up, protocol training, conduct, site monitoring and close out. These may include, but are not limited to:
- Assist in the preparation / prepare study protocols, data capture forms, test article documentation and study reports
- Maintaining study files in accordance with SOPs and regulatory requirements
- Assist/coordinate data management processes including data entry, review, tracking, verification and validation
- Assist /coordinating animal related study activities (i.e. clinical sampling, test article administration, and clinical observations).
- Monitoring all studies appropriately including training of investigators and other study personnel.
• Serve as the principle communication link between the sponsor and study site.
• Able to travel regularly (up to 20%) and independently.
• Contribute to/Leads departmental initiatives
• May be responsible for updating management on project budget and timelines
• May participate in animal welfare activities and other duties as assigned
Manager
Study Management:
Responsible for overall conduct of clinical studies in support of Reference Qualification/Requalification project(s). Ability to execute multiple studies and/or multiple projects. Applies advanced knowledge to design and develop studies, clinical plans and liaises with internal groups to meet project goals. Provides training to internal and external collaborators. May manage the work of other clinical colleagues.
Project Team:
Drives project activities required to reach key project milestones. Interacts with multiple groups including Qualtiy Control, Manufacturing, Regulatory Affairs, Lab Sciences and Global Biologics Research. Facilitates team meetings, manages project resources including budget and time lines. Reports team activities across Zoetis and represents team to management. May manage work of other clinical colleagues. May manage change control process. May provide tecchnical sections of variation. May provide technical expertise within regulatory agency interactions. May participate in technical transfer activities as key technical resource. May participate in animal welfare related activities.
Education and Experience
Associate:
Required: Four-year bachelor's degree in biological or related science with emphasis in microbiology, virology, bacteriology, or immunology. 2 - 5 years of experience.
Preferred: DVM with an advanced degree (MS, PhD, Board Certified) and with post-graduate training in clinical veterinary medicine or in a scientific discipline relevant to animal disease and clinical study design. 7 - 10 years clinical or industry experience.
Technical Skills and Competencies
Minimum:
Demonstration of organizational and interpersonal skills as well as written and oral communication.
Demonstration of initiative, independent thinking, strong organizational and interpersonal skills, and detail orientated.
Competence in Microsoft Word, Excel, PowerPoint.
Desirable: A good understanding of livestock and companion animal disease pathogenesis, husbandry and production medicine. Experience and interest in working with livestock including cattle (dairy/beef), swine and/or poultry, as well as companion animals, which may include horses. Previous experience in a research environment (GCP/GLP) and/or previous experience in research/product development in the animal health industry. Experience as a project leader for biological product research.
Physical Position Requirements
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