Research Scientist – Clinical Study Management 

Posted: Thursday, 11 April 2024
Valid Thru: Saturday, 11 May 2024
Index Requested on: 04/11/2024 07:30:35
Indexed on: 04/11/2024 07:30:35

Location: Fort Dodge, IA, 50501, US

Industry: Advertising and Public Relations
Occupational Category: 15-0000.00 - Computer and Mathematics
Type of Employment: FULL_TIME

Elanco is hiring!

Description:

At Elanco (NYSE: ELAN) – it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today!

Your Role: Research Scientist – Clinical Study Management

As a Research Scientist – Clinical Study Management at Elanco Animal Health, you will play a critical role in managing pivotal, non-pivotal, and regulated studies. You'll serve as a liaison between species teams and Clinical Development Sciences (CDS), ensuring compliance with Good Laboratory Practice Regulations (GLP), Good Clinical Practices (GCP), and other relevant scientific investigations.

Your Responsibilities:

  • Contribute to the design and execution of studies according to GLP, GCP, and pivotal and non-pivotal study requirements.

  • Act as Study Director for pre-clinical GLP safety studies and Study Investigator for GCP, pivotal, and non-pivotal studies.

  • Manage the development and completion of study protocols and final study reports, ensuring compliance with regulations.

  • Coordinate with CDS study staff for protocol training and study execution preparation.

  • Ensure compliance with external and internal guidelines, including SOPs, HSE, and Animal Welfare regulations.

  • Responsible for Good Laboratory Practice (GLP) study conduct, including protocol assessment, results documentation, and reporting.

What You Need to Succeed (minimum qualifications):

  • Education: MS with 4+ years, BS with 7+ years of experience, or Doctorate level education (e.g., PhD, DVM, MD) with 2+ years in a relevant industry.

  • Required Experience: Experience managing clinical study initiation, execution, and completion.

  • Top 2 skills: Thorough understanding of GLP and GCP regulations; Effective communication skills.

What will give you a competitive edge (preferred qualifications):

  • Experience with clinical study management in the Animal health industry.

  • Strong organizational and time management skills.

  • Experience with biological vaccines, small molecules, and large molecules.

  • Experience with or willing to gain experience with Pain and Dermatology models.

Additional Information:

  • Travel: Up to 10%

  • Location: Fort Dodge, IA, USA

Elanco Benefits and Perks:

We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:

  • Multiple relocation packages

  • Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)

  • 8-week parental leave

  • 9 Employee Resource Groups

  • Annual bonus offering

  • Flexible work arrangements

  • Up to 6% 401K matching

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

Responsibilities:

Please review the job description.

Educational requirements:

  • high school

Desired Skills:

Please see the job description for required or recommended skills.

Benefits:

Please see the job description for benefits.

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