Clinical Trial Manager | Greenfield, IN

Detailed Information

  • Location: Greenfield, IN

  • Company: Elanco

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. Position Description This position will function in the efficient and effective management and execution of clinical studies.

The individual will be responsible for continuing to grow and develop capabilities in clinical trial implementation. The incumbent will coordinate, oversee, and monitor clinical studies needed for the registration of global products for Elanco. The individual will maintain an excellent working knowledge of government regulations and policies pertaining to clinical trials, VICH-GCP

guidelines, company Standard Operating Procedures (SOPs), and assigned study protocols. The position will interact with US research scientists and the global research and development teams 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 challenges 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 Manages, plans, and coordinates multiple clinical trial activities Provides comprehensive support to the study team Assists scientists with reviewing/revising study protocols Assists Data Management with electronic data capture design Performs monitoring duties for assigned sites Performs routine activities such as facilitating site recruitment and site training Coordinates the oversight of study initiation, in-life, and close-out activities in order to ensure compliance with the protocol and project objectives Assists with addressing QA audits, as needed 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, to ensure projects are moving forward as planned Assists with study planning, contracting, invoicing, and budgeting Assists scientists with reviewing/revising Final Study Reports Mentors study monitors and administrators Manages other job responsibilities and tasks, as needed, and determined by line manager Minimum Qualification (education, experience and/or training, required certifications) Bachelor's degree in a science or health related field and/or 5+ years of applicable experience and a/t least 5 years experience in management and execution of clinical studies 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.

Knowledge of animal health concepts enabling contributions to project plans. This position does require 50%+ travel Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, interactionual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

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