Require Clinical Research Associate at Dr. Reddy's Lab

Dr. Reddy's Laboratories is an Indian multinational pharmaceutical company located in Hyderabad, Telangana, India. The company was founded by Kallam Anji Reddy, who previously worked in the mentor institute Indian Drugs and Pharmaceuticals Limited. Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can’t Wait. We started in 1984 with a modest investment, 20 employees and a bold vision.

Post : Clinical Research Associate

Job Description
• Responsible to monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), and study protocols under supervision of Clinical Operations Manager/ Clinical Research Specialist.
• Responsible to perform study site feasibility, qualification, initiation, monitoring and close-out activities (remotely/ on-site) under supervision in line with study specific project management/ sponsor oversight plan and apply judgment and knowledge to independently resolve site issues, questions, and concerns. 
• Support Clinical Operations Manager/ Clinical Research Specialist to prepare for project kick-off/ investigator’s meeting.
• Will be desirous to build and maintain relationships with investigators and site staff. 
• Will be responsible to address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation and communication.

• Responsible for documentations under supervision and ensure maintenance of Trial Master File/ Sponsor Oversight File in line with study specific project management/ sponsor oversight plan. 
• Support study sites in making Ethics Committee submissions under supervision in line with study specific project management/ sponsor oversight plan. 
• Responsible to review & follow-up on site payments. 
• Assist with data query resolution process for site, Clinical Research organisation (CRO) and Sponsors along with Clinical Data Management in line with study specific project
• management/ sponsor oversight plan.
• Responsible to work collaboratively with the study teams with the review, revision and writing of protocols, Case Report Forms (CRF) and other required documents for clinical research studies.

Candidate Profile
Master degree in pharmacy/ life science/Biology/Biotechnology/ Biochemistry/Diploma in Clinical Research

Technical Skills
• Experience in Clinical Trial operations.
• Proficiency in conducting Market research and analysis.
• Knowledge of regulatory requirements and guidelines such as Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
• Ability to evaluate medical research data and proficient knowledge of medical terminology
• Proficiency in using EDC systems for data collection and management in clinical trials.
• Understanding of pharmacovigilance processes.
• Strong MS office Skills.

Behavioral Skills
• Excellent communication, negotiation, and interpersonal skills.
• Excellent project management skills.
• Strong analytical and problem-solving abilities with a keen eye for detail.
• Result oriented and passionate about delivering value.

Additional Information
Experience : 2 - 5 years
Qualification : M.Pharm, M.Sc
Location : Hyderabad
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : IPDO
End Date : 25th April 2025