(Archived) Clinical Research Consultant- Clinical Operations (Teleworker)

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.

This role will monitor clinical and laboratory studies and ensure compliance with internal and external guidelines as well as applicable regulations.

It will also include assisting in conducting, overseeing, and monitoring studies needed to advance the pilot and pivotal registration for global Farm Animal and Pet Health products. The position will interact with US Scientists, and the research and development teams, globally, to gain regulatory approval of these products.

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.
• Participates in FDA/USDA inspections and interacts with the regulators, as needed.
• Collaborates across all levels within the R&D and commercial organizations as appropriate for the project and phase of development
• Assists in planning studies, preparing study timelines, and assisting 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.

Basic Qualifications:

• Bachelor's degree in a science or health related field
• 5+ years of experience in monitoring animal health clinical trials

Additional preferences:

• 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.

Additional information:

• Expected travel: approximately 25% +

Notification of Drug testing and Background Checks

Elanco conducts urinalysis drug testing as a mandatory part of its pre-employment application and background check process after acceptance of a conditional offer of employment by an applicant. The drug testing will be conducted by a certified laboratory/testing service selected by Elanco, in accordance with the procedures required by applicable state and federal law. Additionally, Elanco requires successful completion of a urinalysis drug test if it has reasonable suspicion that an employee is under the influence of drugs or alcohol which adversely affects or could adversely affect the employee's job performance as allowed by applicable law. Tested applicants will be given a copy of any positive test result. All test results shall be considered confidential and shall not be disclosed by Elanco, other than to those persons for whom such disclosure is necessary. Positive test results, or a refusal to consent to and participate in pre-employment drug testing, shall be grounds for denial of employment. Cooperation in scheduling the testing is important for processing an application for employment. By signing your acceptance to an offer of employment, you consent to be drug tested and acknowledge you have thoroughly read the foregoing notice and policy, and you understand and agree that in order to be considered for employment with Elanco, you will be required to comply with Elanco's drug testing policy. Elanco's background check requirements also include but are not limited to an acceptable criminal background check, educational verification, job history verification and motor vehicle report (if required to drive a company vehicle). If appropriate for the role, as outlined on the job posting, successful completion of Post Offer Exam, Work Simulation and/or Administrative Skills Testing may also be required.

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