Clinical Operations Specialist – TCS

Tata Consultancy Services (TCS), a global leader in IT and life sciences solutions, is hiring Clinical Operations Specialists in Mumbai, India. This role is ideal for professionals seeking to advance their careers in clinical research operations, clinical data management, and clinical study support within a top-tier organization.

TCS offers a dynamic environment, working with global pharmaceutical clients and ensuring compliance across multiple clinical trials.

Key Responsibilities

As a Clinical Operations Specialist at TCS, you will:

• Organize study start-up teleconferences with internal and external study teams.
• Assist in study start-up activities and ensure drug shipment compliance as per Client SOPs.
• Update and maintain study data accurately within Client systems and ensure data integrity.
• Support the clinical study team in meeting deliverables and maintaining inspection readiness.
• Aid in study closeout activities, ensuring all processes align with SOPs and documentation standards.
• Compile and generate Clinical Study Report (CSR) Modular Appendices.
• Manage and archive essential documents per Client Sponsor TMF SOP.
• Ensure key performance indicators (KPIs) are achieved for each assigned study.

Qualifications

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related field.
• 2–5 years of relevant experience in clinical operations, TMF management, or study start-up.
• Strong understanding of ICH-GCP guidelines, clinical trial documentation, and regulatory compliance.
• Excellent communication, coordination, and data management skills.
• Ability to work independently in a fast-paced, deadline-driven environment.

Benefits of Working with TCS

• Work with a global life sciences leader serving top pharmaceutical clients.
• Exposure to end-to-end clinical trial operations and regulatory documentation.
• Opportunities for career growth and professional development within TCS Life Sciences.
• Competitive salary and benefits package.

How to Apply

Interested candidates can send their CVs directly to the TCS Talent Acquisition Specialist:
📧 Babeeta.shahi@tcs.com

Location: Mumbai, Maharashtra, India
Employment Type: Full-time, On-site