Elanco is hiring for the position of Consultant – R&D Support at its Bangalore, India location. The role focuses on clinical research operations, scientific authoring, study documentation management, clinical project tracking, and technical system maintenance.
Candidates with a DVM and/or PhD qualification and at least 2 years of experience in clinical research operations, scientific writing, or study support can apply.
Job Details
| Particulars | Details |
|---|---|
| Company | Elanco |
| Position | Consultant – R&D Support |
| Job Location | Bangalore, India |
| Job Type | Full Time |
| Requisition ID | R0027807 |
| Qualification | DVM and/or PhD |
| Experience | 2+ Years |
| Department | Research & Development (R&D) |
Position
Consultant – R&D Support
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The selected candidate will support clinical trials and research projects through scientific documentation, remote study oversight, Study Master File management, clinical project tracking, and coordination of R&D systems and material shipments.
Key Responsibilities
- Clinical Trial Support: Provide remote support to Sponsor Representatives (SRs) and Global Clinical Leads (GCLs), ensuring study oversight, compliance, and data quality.
- Document Management: Manage document transfers, data corrections, digital assembly, quality control, and maintenance of Study Master Files (SMF/TMF).
- R&D System Maintenance: Maintain study tracking, project management, document management, and budget information in primary R&D systems, including Veeva.
- Study Tracking: Monitor global study milestones, deliverables, project timelines, and provide status reports to Global Clinical Leads.
- Scientific Authoring: Prepare clinical protocols, Final Study Reports (FSRs), abstracts, summaries, manuscripts, and other regulatory and scientific documents.
- Operational Support: Coordinate site contracting, procurement activities, and adverse event/pharmacovigilance reporting requirements.
- IVP Management: Coordinate R&D material shipments, documentation, requirements, and timelines with internal technical project teams.
- Issue Management: Identify, resolve, and escalate study-related issues to maintain data integrity and regulatory compliance.
Eligibility / Qualifications
Candidates must meet the following requirements:
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- DVM and/or PhD qualification.
- Minimum 2 years of experience in clinical research operations, scientific writing, or study support.
- Understanding of FDA, USDA, EMA, ICH, GLP, and GCP guidelines.
- Understanding of clinical operations and clinical development functions.
- Detailed knowledge of clinical protocol design, implementation, and the drug development process.
- Experience in clinical project management and complex problem-solving.
- Ability to prepare and edit technical documents, including protocols and protocol amendments.
- Ability to collaborate with global teams across the USA, EU, and Australia.
- Ability to coordinate effectively with internal and external clinical site personnel.
Required Skills
- Clinical Research Operations
- Clinical Project Management
- Scientific and Regulatory Writing
- Clinical Protocol Development
- Study Master File (SMF/TMF) Management
- Veeva Platform
- Clinical Trial Management Systems (CTMS)
- Study Tracking and Documentation Management
- FDA, USDA, EMA, ICH, GLP and GCP Guidelines
- Pharmacovigilance and Adverse Event Reporting
- Microsoft Office Suite
- Microsoft Project
- Cross-functional Team Collaboration
- Problem-solving and Analytical Skills
- English Communication Skills
