Dr. Reddy’s Laboratories, a globally renowned pharmaceutical company, is hiring for the position of Clinical Research Associate in Hyderabad. With a legacy of innovation and excellence, Dr. Reddy’s Laboratories is committed to accelerating access to affordable and innovative medicines. If you have a passion for clinical research and meet the required qualifications, this is an excellent opportunity to join a leading multinational organization.
About Dr. Reddy’s Laboratories
Founded in 1984 by Dr. Kallam Anji Reddy, Dr. Reddy’s Laboratories has grown into a global pharmaceutical giant with a presence in 66 countries. The company employs over 24,000 professionals dedicated to improving global health. With state-of-the-art research and development centers and manufacturing facilities, Dr. Reddy’s Laboratories continues to lead the way in the pharmaceutical and healthcare industry.
Job Title: Clinical Research Associate
Location: Hyderabad, India
Industry Type: Pharma / Healthcare / Clinical Research
Functional Area: Clinical Operations
Key Responsibilities
As a Clinical Research Associate at Dr. Reddy’s Laboratories, you will play a pivotal role in managing clinical trials and ensuring compliance with regulatory standards. Your responsibilities will include:
- Study Start-Up Activities: Facilitating site qualification visits, collecting essential documents, and ensuring regulatory and EC submissions.
- Site Management: Initiating studies, providing protocol training, reviewing informed consent forms, and performing source data verification (SDV).
- IP Accountability: Overseeing the supply, storage, and administration of investigational products (IP) and ensuring proper documentation.
- Site Contracts and Payments: Coordinating clinical trial agreements, reviewing site invoices, and ensuring timely payments.
- Stakeholder Liaison: Collaborating with internal and external stakeholders, including data management, safety teams, and medical teams.
- Compliance: Ensuring adherence to protocol, SOPs, ICH-GCP guidelines, and regulatory requirements.
- Trial Master File (TMF) Maintenance: Reviewing and maintaining TMF for inspection readiness.
Candidate Profile
- Educational Qualification: Master’s degree in Pharmacy, Life Sciences, Biology, Biotechnology, Biochemistry, or a Diploma in Clinical Research.
- Experience: 2-5 years of experience in clinical trial operations.
Skills and Attributes
- Technical Skills:
- Proficiency in clinical trial operations and market research.
- Knowledge of regulatory guidelines such as GCP and ICH.
- Familiarity with EDC systems and pharmacovigilance processes.
- Strong MS Office skills.
- Behavioral Skills:
- Excellent communication, negotiation, and interpersonal skills.
- Strong analytical and problem-solving abilities.
- Detail-oriented with a result-driven approach.
