Clinical Study Monitor - Animal

As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.

Functions, Duties, Task:

Key Leadership Responsibilities

• Proactively search for solutions.
• Work effectively and flexibly within and across all Elanco R&D teams and external collaborators to achieve overall Elanco R&D deliverables.
• Create a positive work environment that is aligned with company objectives.
• Provide and accept challenge to deliver innovative technical solutions and create an innovative culture.
• Demonstrate Elanco values of integrity, respect, and excellence.
• Contribute to an engaging culture by demonstrating Elanco behavioral pillars of involve, deliver, innovate, and own
• Identify and utilize methods to deliver individual objectives in a high quality, timely, cost-effective manner.
• Provide information to facilitate accurate and timely project and budget forecasts.

Key Technical Responsibilities

• The incumbent manages and plans, with appropriate direction, multiple activities of clinical trials/studies and provides comprehensive support to the scientists assigned to the farm animal or companion animal trial/study.
• Responsible for preparation and shipment of clinical trial/study site documentation, critical regulatory documents, and general correspondence with the sites.
• Verifies drug accountability at initiation and closeout visits.
• Works independently to assess compliance with study protocols by interacting with Investigator sites or third-party contract facilities.
• Verifies study data using applicable Data Management tools and study monitoring processes to ensure data integrity and quality.
• Manages all query communication with the study/trial sites.
• Assists with addressing QA audits.
• Performs routine activities such as facilitating site recruitment, site training and study initiation, in-life and close-out activities in order to ensure site activities are in accordance with project objectives.
• Collaborates across all levels within the R&D and commercial organizations as appropriate for the project and phase of development.
• Assists in the development of submissions or dossiers to regulatory agencies around the world
• Manage other job responsibilities and tasks, as needed, and determined by manager and/or Global Clinical Development Sciences management.

Minimum Qualification (education, experience and/or training, required certifications):

• Bachelor's degree in a science or health related field and/or 2+ years of applicable experience or a Master’s degree in a science or health related field
• Speaks and writes clearly and succinctly in a variety of settings and styles; gets messages across that initiate appropriate actions.
• Working knowledge of computer applications including MS Word, Excel and Adobe document management.
• Basic knowledge of animal health concepts enabling contributions to project plans.
• This position will require 50%+ traveling in the USA to various clinical study sites

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status