Dr. Reddy’s Laboratories Ltd. is a prominent global pharmaceutical company dedicated to providing innovative and affordable healthcare solutions. Since its inception in 1984, Dr. Reddy’s has expanded across 66 countries, offering a range of services including research and development, manufacturing, and commercialization of drugs. With a workforce of over 24,000 employees, Dr. Reddy’s vision is to reach over 1.5 billion patients worldwide by 2030. The company stands for affordability, access, and innovation, ensuring sustainability in all its operations. Its values center on integrity, transparency, and respect for people, planet, and purpose, creating a positive impact on both society and the environment.
Dr. Reddy’s is committed to diversity and inclusion, embracing a workforce without regard to race, gender, or other protected statuses. The company believes in nurturing a diverse and talented team to drive innovation and fulfill its global mission.
Responsibilities in the Clinical Trial Associate (CTA) Job
As a Clinical Trial Associate (CTA) at Dr. Reddy’s Laboratories, you will be playing an essential role in supporting clinical studies and assisting the Clinical Operations Department. Here’s a breakdown of your responsibilities:
- Administrative Support: Provide general administrative assistance to the clinical operations team, ensuring efficient operations.
- Document Review & Quality Control: Assist with the review of study-specific documentation, including informed consent forms (ICF), study plans, and e-CRF, ensuring compliance with regulatory guidelines.
- Study Metrics & Tracking: Help in maintaining study trackers, tools, and reports, including tracking Investigator and third-party payments.
- eTMF Management: Ensure study documents are submitted to the eTMF, assist with periodic audits, and resolve findings.
- Study Oversight: Participate in clinical monitoring oversight, coordinate Investigator Meetings, and assist in customizing clinical site contracts and budgets.
- Communication & Coordination: Liaise with clinical sites for specific requests and support internal and external team meetings by generating agendas and minutes.
Qualifications Required
To apply for the Clinical Trial Associate role at Dr. Reddy’s Laboratories, candidates must meet the following educational and professional qualifications:
- Educational Background: A Graduate or Master’s degree in pharmacy, life sciences, biology, biotechnology, biochemistry, or a diploma in clinical research.
- Experience: A minimum of 1-3 years of clinical trial experience, providing foundational knowledge in clinical operations and regulatory requirements.
- Regulatory Knowledge: Familiarity with Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines is essential for success in this role.
Skills for the Clinical Trial Associate Role
In addition to educational and professional qualifications, the ideal candidate should possess the following skills:
- Technical Skills:
- Strong understanding of clinical trial operations.
- Proficiency in using EDC systems for data management in clinical trials.
- Excellent knowledge of regulatory guidelines such as GCP and ICH.
- Strong MS Office skills for creating documents, presentations, and reports.
- Behavioral Skills:
- Effective communication, negotiation, and interpersonal skills.
- Excellent project management capabilities, with the ability to handle multiple tasks efficiently.
- Strong analytical and problem-solving skills, with a sharp attention to detail.
- Passion for delivering value and results-oriented attitude.
