Clinical Trial Assistant (CTA)

Why This Role Matters
Clinical Trial Assistants (CTA) play a crucial operational role in ensuring that global clinical trials run efficiently, remain compliant with regulatory standards, and maintain inspection-ready documentation. In therapeutic areas such as oncology, cardiology, pulmonology, and immunology, operational precision directly impacts patient safety, data integrity, and successful drug development timelines.

Job Description
ICON Strategic Solutions is hiring a Clinical Trial Assistant (CTA) for its Mumbai office (office-based/hybrid structure as per business needs). The role supports global clinical study teams in documentation management, regulatory submissions, system updates, and cross-functional coordination. The CTA ensures essential documents, milestones, and compliance requirements are maintained throughout the study lifecycle.

Key Features of the Role:
• Full-time position
• Office-based in Mumbai, India
• Exposure to global clinical trials
• Work across oncology, cardiology, pulmonology, and immunology studies
• Hands-on experience with Veeva Vault, CTMS, and EDC systems
• Opportunity to work within a global CRO environment

Responsibilities
• Support global study teams with TMF maintenance and documentation
• Manage and update Veeva Vault, CTMS, and EDC platforms
• Assist in study start-up activities and site document tracking
• Coordinate meetings, maintain minutes, and manage training documentation
• Track essential documents, study milestones, and key metrics
• Support Ethics Committee (EC) and Health Authority (HA) submissions
• Assist with site payments and vendor coordination
• Maintain inspection-ready documentation
• Support audits and regulatory inspections

Required Qualifications
• 1–2 years of experience as a Clinical Trial Assistant
• Experience in global clinical trial operations
• Knowledge of ICH-GCP guidelines and regulatory processes
• Strong documentation and organizational skills
• Proficiency in clinical systems (Veeva Vault, CTMS, EDC)
• Excellent communication skills

Educational Requirements:
• Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or related healthcare field

Experience and Skills:
• Hands-on experience with EC and HA submissions
• Understanding of essential clinical trial documentation
• Ability to manage multiple tasks in a structured environment
• Strong attention to detail
• Experience coordinating with cross-functional global teams

Age Eligibility:
As per company norms

Salary Insights
Salary not disclosed. Competitive compensation and country-specific benefits offered by ICON.

Company Overview
ICON plc is a world-leading healthcare intelligence and clinical research organization supporting pharmaceutical, biotechnology, and medical device companies. ICON fosters innovation, operational excellence, and inclusivity while driving clinical development globally. The company offers comprehensive benefits, including health insurance, retirement planning, employee assistance programs, and work-life balance initiatives.

FAQs

Is prior CTA experience mandatory?
Yes, 1–2 years of experience in global clinical trials is required.

Is this a remote role?
The role is primarily office-based in Mumbai, with flexibility as per company guidelines.

Is knowledge of Veeva Vault necessary?
Yes, hands-on experience with Veeva Vault, CTMS, and EDC platforms is expected.

Does the role involve regulatory submissions?
Yes, including EC and Health Authority submissions.

What therapeutic areas will I work in?
Oncology, cardiology, pulmonology, and immunology studies.

Application Tips
• Highlight experience in TMF and regulatory submissions
• Mention specific systems used (Veeva, CTMS, EDC)
• Demonstrate understanding of ICH-GCP compliance
• Showcase strong organizational and documentation skills
• Emphasize ability to work in global cross-functional teams