Associate Principal Scientist, Clinical Research

Responsibilities

• Design and conduct clinical studies that adhere to scientific, regulatory, and ethical requirements used for support in the registration of animal health products.
• Design and organize paper and Electronic Data Capture clinical studies by setting objectives, budget, resources, timelines, and study protocol/related documentation.
• Provide overall leadership and support to the clinical study team.
• Identify and select Investigators, laboratories, and/or CROs.
• Apply for the necessary study permits and licenses with the support of local regulatory staff within the specified study timeline.
• Train the study team on the Study Protocol.
• Ensure the timely selection and ordering of study materials.
• Ensure compliance of administrative aspects of the study (budgets and agreements) with the applicable laws and our company's policies and procedures.
• Plan and coordinate the monitoring and data management activities of each study.
• Ensure that the study is conducted according to legal requirements, Good Clinical Practice, and the applicable internal policies and procedures.
• Prepare the Final Study Report.
• Maintain contact with all stakeholders (project leader, regulatory affairs, quality assurance, etc.) and keep them informed of the study progress.
• May serve as the Global Clinical Research representative in the project team.
• Assume responsibility for certain monitoring and data management tasks (e.g., User Acceptance Test of electronic Case Report Forms).
• Develop and maintain a network of internal and external clinical and scientific contacts and key opinion leaders in relevant fields.
• Serve as a contact and liaison with other internal departments on specific projects, and with external partners, such as universities or regulatory authorities.
• Prepare critical summaries and expert reports to management and/or for submission to regulatory agencies.
• Supervise trainees and provide mentorship and support to other Global Clinical Research staff.
• Provide scientific and technical support to the marketing groups for key molecules/products and clinical research expertise upon request.
• Conduct post-marketing studies.
• Prepare scientific publications according to the needs of the company.

Qualifications

• Doctor of Veterinary Medicine, OR equivalent veterinary degree.
• Four (4) years in clinical research or a similar research role.
• Experience in a clinical study-related role.
• Strong scientific writing ability.
• Principled verbal and written communications.
• Proficient in MS Office applications.
• Understanding of Good Clinical Practice guidelines.

Required Skills

Biomarker Assay Development, Clinical Site Management, Clinical Study Design, Clinical Trials Operations, Detail-Oriented, Ethical Compliance, Ethical Standards, Good Clinical Practice (GCP), Medical Writing, Multiple Therapeutic Areas, Patient Recruitment, Scientific Writing, Veterinary Research