Consultant - R&D Support

Overview

Consultant role in R&D Support at Elanco, driving clinical trial and project acceleration through scientific authoring, remote study support, study master file oversight, material shipment coordination and technical system management.

What you'll do

• Conduct remote support activities and study oversight to ensure compliance and data quality, acting as a remote extension of the clinical team to identify and resolve or escalate study issues.
• Support Sponsor Representatives (SRs) and Global Clinical Leads (GCLs) via a dotted-line reporting relationship.
• Manage document transfer for data entry and/or corrections.
• Manage the real-time digital assembly, QC and maintenance of the Study Master File (SMF/TMF), including in APEX systems or working environments such as SharePoint, ensuring internal documents adhere to Elanco guidelines and regulatory templates.
• Serve as primary lead for system updates (study tracking, project management, document management and budgets), keeping study parameters, site data and project milestones accurate and audit-ready.
• Proactively track global study milestones and deliverables, providing GCLs with critical path visibility and status reporting.
• Prepare regulatory and scientific documents, including protocols, Final Study Reports (FSRs), study documentation, abstracts, summaries and manuscripts.
• Manage site contracting with the Procurement interface and oversee in-life AE/PV reporting requirements, including threshold detection, to meet global regulatory timelines.
• Support and partner with internal Technical Project Leads (TPLs), GCLs and R&D material management to coordinate timing, requirements and documentation for IVP material shipment.

What you'll need

• DVM and/or PhD with 2+ years of 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.
• 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 and overall drug development.
• Ability to effectively interface with clinical personnel at internal and external clinical sites.
• Ability to collaborate effectively with global teams in the USA, EU and Australia.
• Ability to write and edit technical documents, such as protocols and protocol amendments.
• Detailed and team-oriented, with excellent cross-functional team leadership and participation skills.
• Excellent interpersonal, verbal and written communication skills in English.
• Proficiency with CTMS and document management (Veeva), Microsoft Office suite and Microsoft Project.

Details

• Location: Bangalore, India.