ICON Strategic Solutions is seeking candidates for the Senior Clinical Trial Associate (CTA) position to support global clinical trial operations across oncology, cardiology, pulmonology, and immunology studies. The role involves clinical trial documentation, Trial Master File (TMF) maintenance, clinical systems management, study start-up support, and coordination with global study teams.
Candidates with 3–5 years of experience as a Clinical Trial Associate in global clinical trials and hands-on experience with Veeva Vault, CTMS, and EDC systems can review the job requirements and apply online.
Job Details
| Particulars | Details |
|---|---|
| Company | ICON Strategic Solutions |
| Job Title | Senior Clinical Trial Associate |
| Job Requisition ID | JR155460 |
| Qualification | Relevant degree and clinical trial experience |
| Experience | 3–5 years as a Clinical Trial Associate |
| Location | India |
| Preferred Candidates | Mumbai-based candidates |
| Work Arrangement | Office With Flex |
| Employment Type | Full-time |
| Job Posting | Posted Today |
Position Overview
The Senior Clinical Trial Associate will support global clinical study teams by managing essential trial documentation, maintaining clinical systems, coordinating study activities, and ensuring compliance with clinical trial and regulatory requirements.
Key Responsibilities
- Support global study teams with trial documentation, TMF maintenance, and compliance.
- Manage and update Veeva Vault, Clinical Trial Management System (CTMS), and Electronic Data Capture (EDC) platforms.
- Assist with study start-up, site document collection, and tracking.
- Coordinate meetings, meeting minutes, training documentation, and trial communications.
- Track essential documents, study milestones, and key study metrics.
- Coordinate with internal teams, vendors, and site staff to ensure timely deliverables.
- Maintain inspection-ready documentation and support audits.
Eligibility and Qualifications
Candidates should meet the following requirements:
- Experience: 3–5 years working as a Clinical Trial Associate in global clinical trials.
- Clinical Trial Activities: Hands-on experience with Ethics Committee (EC) submissions, Health Authority (HA) submissions, site payments, essential clinical trial documentation, and tracking.
- Clinical Operations: Strong understanding of clinical operations processes, ICH-GCP guidelines, and regulatory requirements.
- Clinical Systems: Proficiency in Veeva Vault, CTMS, and EDC platforms.
- Communication: Strong communication, documentation, and organizational skills.
- Work Environment: Ability to work effectively in a fast-paced, structured, cross-functional global environment.
Required Skills
- Clinical Trial Operations
- Trial Master File (TMF) Management
- Veeva Vault
- Clinical Trial Management System (CTMS)
- Electronic Data Capture (EDC)
- Ethics Committee Submissions
- Health Authority Submissions
- Site Payment Coordination
- Study Start-Up and Site Documentation
- ICH-GCP and Regulatory Compliance
- Audit Readiness
- Cross-Functional Coordination
Salary and Benefits
ICON offers a total rewards package that may include:
- Competitive base salary and performance-related incentives
- Medical, dental, and vision coverage, where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
Benefits may vary by role and location.
