Clinical Research Associate (Clinical Trials)

Roles & Responsibilities:
• Conduct site feasibility and identify potential investigators
• Negotiate study budgets and finalize investigators, sites, CDA, and study contracts
• Prepare and submit study documents for Ethics Committee (EC) approvals
• Oversee investigational product (IP) dispensing, inventory management, and reconciliation
• Ensure timely site initiation, monitoring, and close-out visits with proper documentation
• Train investigators and site staff on study protocol, procedures, and GCP principles
• Monitor patient recruitment, data entry, SDV, and query resolution
• Ensure timely reporting of SAEs and SUSARs in compliance with regulatory and PV policies
• Identify site risks, perform analysis, and implement CAPA where required
• Coordinate with in-house teams or CRO partners for data management, statistical analysis, and database lock (DBL) activities

Qualification:
• Bachelor’s or Master’s degree in Life Sciences (Biology, Chemistry, Nursing, Pharmacy, Public Health, etc.)
• OR Postgraduate Diploma in Clinical Research

Experience:
• 1–5 years of relevant experience in Clinical Research

Skills:
• Strong knowledge of GCP guidelines and clinical trial regulations
• Experience in Phase III and Phase IV clinical trials
• Site management and monitoring expertise
• Understanding of SAE/SUSAR reporting processes
• Cross-functional collaboration skills
• Good communication and documentation abilities
• Strong analytical and problem-solving skills

About the Organization:
Sun Pharmaceutical Industries Ltd is one of the world’s leading specialty generic pharmaceutical companies with a strong global presence. The organization focuses on innovation, quality, and patient-centric healthcare solutions while fostering a culture of growth, ownership, and collaboration.