Lilly Research Scientist-Study Management in Fort Dodge, Iowa
Title Research Scientist-Study Management
City Fort Dodge
State / Province Iowa
Region North America
Company Overview Elanco is a global research-based company that develops and delivers product and services to enhance animal health and production. We value innovation, both in scientific research and daily operations, and strive to cultivate a collaborative work environment for more than 7,000 employees worldwide. Founded in 1954, Elanco is a division of Lilly. Our worldwide headquarters and research facilities are in Greenfield, Indiana
Responsibilities Responsible for the management of clinical trials in Elanco sites and regional Contract Research Organizations (CROs) as needed. Further serves as a liaison between species teams and the Global Operations (GO) organization to support experimental design, scientific interpretation of results, and production of any materials for patents or publications
Functions, Duties, Tasks:
Assist in the design of non-GxP and GCP clinical trials to be executed by GO.
Aid in the design of scientific investigations involving animal models and support any potential patent or publication generation.
Participate in the execution of clinical events in managed trials.
Manage the development and completion of study protocols.
Manage the development and completion of final study reports.
Assemble and ensure IACUC approval of trials.
Coordinate with study execution staff for protocol training and study execution preparation.
Support the development and maintenance of all study-related SOPs, templates, and forms.
Provide data management and monitoring support for clinical trials, as needed.
Interact with species team delegates to gain site visibility to short, medium, and long term study needs.
Work according to, and ensure the compliance with external and internal guidelines (e.g. SOP’s, GXP, HSE and AW) as well as applicable regulations.
Ensure and maintain communication between Sponsor’s Rep, Investigator, Study Execution Team, Site Veterinarian(s), or Study Monitor(s) regarding conduct of studies.
Organize and support IVP supply management and assessment of compliance with regulations and guidelines including resolution of site problems to ensure protocol/regulatory compliance.
Further support GO initiatives as able.
- BS / MS with a minimum of 5 years of experience in a relevant industry
Doctorate level education (PhD, DVM, MD, etc.).
Excellent understanding of clinical trial and/or safety study execution and business processes.
Thorough understanding of study design, execution and operations.
Excellent knowledge of GCP and/or GLP and local regulations.
Proven interpersonal skills with demonstrated expertise while working in teams.
Good presentation skills and scientific/technical writing skills
10-20% travel may be needed depending on study location
Lilly 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.
Removal Date 12-Dec-2017