IQVIA India, part of the global IQVIA network, is a leading healthcare and clinical research organization. It specializes in providing advanced analytics, technology solutions, and clinical research services to support life sciences and healthcare industries. IQVIA is known for combining data science with human ingenuity to drive healthcare innovation, helping clients accelerate clinical development and improve patient outcomes.

Responsibilities in the Job As a Clinical Trial Assistant (also referred to as a Clinical Study Administrator) at IQVIA India, you will play a crucial role in supporting the local study team throughout various stages of clinical trials. Key responsibilities include:

• Setting up and maintaining clinical study tracking systems.
• Managing essential documents and ensuring their readiness for regulatory inspection.
• Coordinating document submissions to Ethics Committees (EC) and Institutional Review Boards (IRB).
• Ensuring compliance with local and international regulations, such as ICH-GCP standards.
• Supporting CRAs (Clinical Research Associates) in document collection and overall study management.
• Assisting in the close-out process of studies and ensuring proper archiving of study documents.
• Handling clinical-regulatory documents and ensuring adherence to Submission Ready Standards (SRS).

Qualifications To be eligible for this role, the following qualifications are essential:

• A graduate degree in a life sciences field (e.g., biology, pharmacy, or biochemistry).
• Previous administrative experience, ideally in a medical or life sciences setting.
• Proficiency in MS Office applications and general computer skills.
• Excellent communication skills, particularly in English (spoken and written).
• Strong organizational skills with the ability to manage multiple tasks efficiently.

Skills Required

• Strong interpersonal skills to collaborate with internal teams and regulatory bodies.
• Attention to detail and the ability to manage documents effectively.
• Knowledge of clinical trials and their regulatory requirements is an advantage.
• Experience in handling electronic systems such as eTMF (electronic Trial Master File).
• Commitment to maintaining compliance with company policies, safety, and environmental standards.

How to Apply Interested candidates can easily apply for the Clinical Trial Assistant by Mentioning Subject Line as Clinical Trial Assistant, Sheetal Jamane, at sheetal.jamane@iqvia.com.