Clinical Research Associate

Role Overview

Sun Pharma is looking for a Clinical Research Associate to join its Clinical Research business unit in Mumbai. The role sits within a culture built around continuous improvement, ownership, and teamwork, with an emphasis on personal growth and shared success.

Key Responsibilities

• Assess site feasibility, shortlist potential investigators, negotiate study budgets, and complete investigator, site, CDA, and study contract finalization.
• Prepare and file study documentation needed to secure Ethics Committee approval for each center involved in the study.
• Track, document, and reconcile investigational product dispensing and inventory.
• Make sure site initiation, monitoring, and close-out activities happen on time and that the required reports are completed.
• Train investigators and site staff on the study protocol, study procedures, and Good Clinical Practice principles.
• Support prompt participant recruitment and ensure accurate data entry, source verification, and resolution of queries.
• Ensure adverse event reporting requirements are met, including timely reporting of SAEs and SUSARs to all relevant sites and investigators in line with regulatory requirements and company pharmacovigilance policies.
• Identify risks at sites, analyze gaps, and drive corrective and preventive actions for locations that are not meeting planned expectations.
• Coordinate with internal teams or CRO partners for data management, statistical analysis, statistical analysis reports, and database lock.

Requirements

• Bachelor’s or master’s degree in a health-related or related discipline such as Biology, Chemistry, Nursing, Pharmacy, or Public Health, or a postgraduate diploma in Clinical Research.
• 2 to 5 years of relevant experience in Clinical Research.
• Strong understanding of GCP practices and clinical trial regulatory guidelines.
• Hands-on knowledge of Phase III and Phase IV clinical trials.
• Proven capability in site management.
• Ability to work effectively with cross-functional stakeholders.

About the Company

Sun Pharma describes its workplace as one where employees are encouraged to create their own sunshine, keep improving each day, take ownership of their growth, and succeed together through collaboration and support.

Additional Information

This job description is intended to describe the general nature and level of work for the role. It is not a complete list of duties, responsibilities, or qualifications. The company may update duties over time or assign similar work based on business needs and the employee’s background and experience.

What Success Looks Like

The company emphasizes employee success and well-being, along with access to benefits and opportunities that support both personal and professional development. The role is presented as part of an environment where each day offers a chance to grow, collaborate, and contribute meaningfully.