Dr. Reddy’s Laboratories Ltd. is a global leader in pharmaceuticals, dedicated to delivering affordable and innovative medicines to patients worldwide. With over 24,000 employees across 66 countries, our mission is rooted in science, innovation, and sustainability. We strive to accelerate access to healthcare for over 1.5 billion patients by 2030.
Job Summary:
As a Clinical Research Associate, you will manage end-to-end clinical investigational site activities, ensuring compliance with regulatory requirements, Good Clinical Practices (GCP), and clinical trial protocols. Your role will include conducting feasibility assessments, site qualification visits, and site management throughout the clinical trial process.
Key Responsibilities:
- Facilitate Study Start-up Activities at Clinical Investigational Sites
- Conduct site feasibility and qualification assessments for clinical trials
- Manage collection of essential documents for regulatory submissions
- Provide training to site staff on protocols and clinical trial procedures
- Ensure timely and accurate data collection, entry, and reporting
- Perform IP accountability, monitoring, and reconciliation at sites
- Liaise with internal and external stakeholders for seamless study execution
- Ensure compliance with protocol, ICH-GCP guidelines, and applicable regulations
- Support audits and maintain the Trial Master File for inspection readiness
- Coordinate site payments and contract management
Qualifications:
- Master’s degree in Pharmacy, Life Sciences, Biology, Biotechnology, Biochemistry, or a related field
- 2-5 years of experience in clinical trial operations
- Strong knowledge of GCP and ICH guidelines
- Proficiency in EDC systems and data management
- Excellent project management, communication, and problem-solving skills
- Ability to work independently and manage multiple clinical sites
Benefits:
- Competitive salary and benefits package
- Personalized learning and development programs
- Medical coverage for you and your family
- Relocation support, family support (maternity/paternity), and more
