Consultant - R&D Support

Elanco; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

Elanco is seeking a Clinical Trials Specialist to drive study acceleration, remote study support, and document management across global teams. The role involves regulatory documentation, study master file oversight, and keeping Veeva and related R&D systems audit-ready.

You will partner with Sponsor Representatives and Global Clinical Leads, manage study tracking, and ensure data integrity throughout the end-to-end lifecycle of trial documentation.

Qualifications

• DVM or PhD with 2+ years clinical research operations experience.
• Understanding of FDA, USDA, EMA, ICH, GLP and GCP guidelines.
• Proven track record in clinical project management and problem-solving.
• Ability to interface with clinical personnel and collaborate with global teams.

Responsibilities

• Conducts remote support activities and study oversight to ensure compliance and data quality.
• Manages Study Master File (SMF/TMF) and document transfer, ensuring regulatory templates.
• Maintains primary R&D systems (e.g., Veeva) and ensures audit-ready study parameters.
• Proactively tracks global study milestones and provides status reporting to GCLs.
• Prepares regulatory and scientific documents including protocols and Final Study Reports.
• Oversees site contracting and in-life adverse event/PV reporting to meet timelines.

Skills

Clinical research operations

Scientific writing

Regulatory guidelines

PM & cross-functional leadership

Communication skills

Education

DVM/PhD

Tools

CTMS

Veeva

Microsoft Office

Microsoft Project

Job 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.At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose all to Go Beyond for Animals, Customers, Society and Our People.

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!

Position Description:

Responsible for driving clinical trial and project acceleration through scientific authoring, study support, remote site master file oversight, material shipment coordination, and technical system management. This role will report, via dotted line, and support Sponsor Representatives (SRs) and Global Clinical Leads (GCLs) by performing remote study support activities to ensure data integrity, maintaining the primary R&D systems (e.g., Veeva Platform) for global visibility, and managing the end-to-end lifecycle of study documentation and tracking.

Functions, Duties, Tasks:

• SR and Global Clinical Lead Support:Conducts remote support activities and study oversight to ensure compliance and data quality. Acts as a remote extension of the clinical team to identify and resolve or elevate study issues.
• Document Management:Managing document transfer for data entry and/or corrections. Manages the real-time digital assembly, QC, and maintenance of the Study Master File (SMF/TMF). This may include APEX systems or working environments such as SharePoint. Ensures all internal documents adhere to Elanco guidelines and regulatory templates.
• Primary R&D System Maintenance:Serves as the primary lead for primary system updates (study tracking, project management, document management and budgets), ensuring all study parameters, site data, and project milestones are accurately maintained and audit-ready.
• Study Tracking:Proactively tracks global study milestones and deliverables, providing GCLs with critical path visibility and status reporting.
• Scientific Authoring:Prepares regulatory and scientific documents, including protocols, Final Study Reports (FSRs) and other study related documentation, abstracts, summaries and manuscripts.
• Operational Support:Manages site contracting (Procurement interface) and oversees in-life AE/PV reporting requirements (including threshold detection) to meet global regulatory timelines.
• IVP Management: Support and partnership with internal Technical Project Leads (TPL’s), GCL’s and R&D material management to ensure timing, requirements, and documentation are coordinated for IVP material shipment.

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

• DVM and/or PhD with 2+years clinical research operations experience, scientific writing or study support.
• Understanding of FDA, USDA, EMA, ICH, GLP and GCP guidelines.
• Proven track record showing clear proficiency in clinical project management skills.
• Proven complex problem-solving skills.
• Understanding of clinical operations related to clinical development functions.
• Detailed understanding of all aspects of clinical protocol design and implementation & overall drug development.
• Ability to effectively interface with clinical personnel at internal and external clinical site(s).
• Ability to collaborate effectively with global teams in the USA, EU and Australia
• Ability to write and edit technical documents, such as protocols, protocol amendments,
• Detailed and team oriented with excellent cross-functional team leadership and participation skills.
• Excellent interpersonal, verbal and written communication skills (English) are essential in this collaborative work environment.
• Proficiency with computer programs including CTMS and document management (Veeva), Microsoft Office suite and Microsoft Project.

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

Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job-related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.